Urinary incontinence device and method and stimulation device and method

ABSTRACT

A method for treating urinary incontinence is provided. The method includes providing a device having an expandable portion having an outer surface, a first electrode, and a second electrode, the first and second electrodes coupled to the outer surface of the expandable portion and configured to cause a contraction of a muscle in communication with the electrodes. The method further includes causing the expandable portion to inflate such that the first and second electrodes contact vaginal walls and causing a contraction of a muscle in communication with the electrode.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a Continuation of U.S. application Ser. No.13/458,734, filed on Apr. 27, 2012, titled “Stimulation Device andMethod”, which is related to and claims priority to PCT Application No.PCT/US2011/040714, filed on Jun. 16, 2011, titled “Urinary Device andMethod and Stimulation Device and Method”, which is related to andclaims priority to U.S. Provisional Application No. 61/430,072, filedJan. 5, 2011, and to U.S. Provisional Application No. 61/355,822, filedJun. 17, 2010, all of which are incorporated herein by reference intheir entireties. This application is also a Continuation of U.S.application Ser. No. 13/739,750, filed Jan. 11, 2013, titled “UrinaryIncontinence Device and Method”, which is a Continuation of U.S.application Ser. No. 13/458,857, filed Apr. 27, 2012, titled “UrinaryIncontinence Device and Method”, which claims priority to PCTApplication No. PCT/US2011/040714, filed Jun. 16, 2011, titled “UrinaryDevice and Method and Stimulation Device and Method”, which is relatedto and claims priority to U.S. Provisional Application No. 61/430,072,filed Jan. 5, 2011, and to U.S. Provisional Application No. 61/355,822,filed Jun. 17, 2010, all of which are incorporated herein by referencein their entireties.

BACKGROUND

The present disclosure relates generally to the field of nerve andmuscle stimulation. One aspect of the present disclosure relates to adevice and method for electronic nerve and muscle stimulation, and inparticular, internal tissue stimulation. The present disclosure relatesspecifically a device and method for various medical applications,including the treatment of urinary incontinence in females. Anotheraspect of the present disclosure also relates specifically to a deviceand method for creating a pleasurable sensation in a user usingelectronic nerve and muscle stimulation and/or vibrational nerve andmuscle stimulation.

Urinary incontinence in females has numerous causes but is frequentlytied to the weakening of pelvic floor muscles. Some studies haveindicated a high success rate at relieving incontinence symptoms bystrengthening pelvic floor muscles. Certain exercises may be performedto strengthen muscles in this area. However, the efficacy of dailyexercises is dependent on patient compliance with the prescribedexercise regimen and patient compliance with the exercise regimen may bepoor.

Some studies have indicated that more tightened and toned pelvic floormuscles increase the power and intensity of the female orgasm. Certainexercises may be performed to strengthen muscles in this area. Further,stimulation of particular nerves and muscles may be used to generate apleasurable or enjoyable feeling.

SUMMARY

One embodiment of the disclosure relates to a method for treatingurinary incontinence including providing a device having an expandableportion having an outer surface, a first electrode, and a secondelectrode, the first and second electrodes coupled to the outer surfaceof the expandable portion and configured to cause a contraction of amuscle in communication with the electrodes. The method further includescausing the expandable portion to inflate such that the first and secondelectrodes contact vaginal walls and causing a contraction of a musclein communication with the electrode.

Another embodiment of the disclosure relates to an apparatus for thetreatment of urinary incontinence including a shaft and a balloonsurrounding at least a portion of the shaft. The device further includesan electrode coupled to a first portion of the balloon, the electrodeconfigured to cause a contraction of at least one muscle incommunication with the electrode, and a second portion of the balloonhaving a thickness less than the first portion of the balloon. Theballoon inflates in a radially non-uniform manner in response to thedifference in thicknesses of the first portion and the second portion.

Another embodiment of the disclosure relates to a system for treatingurinary incontinence including a member comprising an expandableportion, an electrode disposed on the expandable portion, a memory, andprocessing electronics configured to cause a stimulation of a user'svaginal muscle in communication with the electrode in response to datastored in the memory.

Another embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including an expandableportion configured to assume a plurality of states of expansion betweenminimum expansion and maximum expansion and a vibrating elementextending away from the outer surface of the expandable portion.

Another embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including a shaft having aproximal end and a distal end, the proximal end being interconnected toa housing, and an operative portion located between the proximal end andthe distal end and configured to be located within a vagina when thedevice is in an inserted position. Only one balloon circumferentiallysurrounds the operative portion of the shaft, and a first electrode anda second electrode are coupled to the outer surface of the balloon andconfigured to cause a contraction of a muscle in communication with theelectrodes. The balloon is configured to inflate such that the first andsecond electrodes press against at least one vaginal wall.

Another embodiment of the disclosure relates to a method of toningpelvic floor muscles including providing a device having an expandableportion having an outer surface, a first electrode, and a secondelectrode, causing the expandable portion to inflate such thatelectrodes contact at least one vaginal wall, and causing a contractionof a muscle in communication with the electrode. The first and secondelectrodes are coupled to the outer surface of the expandable portionand configured to cause a contraction of a muscle in communication withthe electrodes.

Another embodiment of the disclosure relates to a stimulation device forcreating a pleasurable sensation in a user including a shaft having aproximal end and a distal end, the proximal end being coupled to ahandle, an operative portion located between the proximal end and thedistal end and configured to be located within a vagina when the deviceis in an inserted position, and an expandable portion comprising anouter surface and configured to assume a plurality of states ofexpansion between minimum expansion and maximum expansion, theexpandable portion circumferentially surrounding the operative portionof the shaft. The device further includes a first electrode, a secondelectrode, a first vibrating element, and a second vibrating element,the first electrode coupled to a first portion of the outer surface ofthe expandable portion, the second electrode coupled to a second portionof the outer surface of the expandable portion, the first and secondelectrodes configured to cause a contraction of a muscle incommunication with the electrodes, the first vibrating element extendingaway from the outer surface of the expandable portion and configured toimpart vibration to a user's Gräfenberg Spot; and the second vibratingelement configured to impart vibration to a first portion of user'sbody. The device further includes a pump in communication with theexpandable portion and configured to cause inflation of the expandableportion such that at least one of the first electrode, the secondelectrode, and the first vibrating element press against a vaginal wall,and processing electronics configured to cause an electrical signal inthe electrodes, to control an aspect of vibration of the first vibratingelement, and to control an aspect of vibration of the second vibratingelement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medical device, shown according to anexemplary embodiment.

FIG. 2 is a perspective view of a portion of the device of FIG. 1, shownaccording to an exemplary embodiment.

FIG. 3 is a bottom plan view of the device of FIG. 1, shown according toan exemplary embodiment.

FIG. 4 is an exploded perspective view of a portion of the device ofFIG. 1, shown according to an exemplary embodiment.

FIG. 5 is a longitudinal cross-section view of the device taken alongline 5-5 of FIG. 1, shown according to an exemplary embodiment.

FIG. 6A is a radial cross-section view of the device taken along line6-6 of FIG. 1 in a deflated state, shown according to an exemplaryembodiment.

FIG. 6B is a radial cross-section view of the device taken along line6-6 of FIG. 1 but showing the device in an inflated state, according toan exemplary embodiment.

FIG. 7 is a front view of a control unit of the device of FIG. 1, shownaccording to an exemplary embodiment.

FIG. 8 is a schematic block diagram of the device of FIG. 1, shownaccording to an exemplary embodiment.

FIG. 9 is a schematic block diagram of the processing electronics of thedevice of FIG. 1, shown according to an exemplary embodiment.

FIG. 10 is a schematic flow chart of a process for treating urinaryincontinence, shown according to an exemplary embodiment.

FIG. 11 is a schematic flow chart of a process for treating urinaryincontinence, shown according to another exemplary embodiment.

FIG. 12 is a perspective view of a stimulation device, shown accordingto an exemplary embodiment.

FIG. 13 is a perspective view of a portion of the device of FIG. 12,shown according to an exemplary embodiment.

FIG. 14 is a bottom plan view of the device of FIG. 12, shown accordingto an exemplary embodiment.

FIG. 15 is a top plan view of the device of FIG. 12, shown according toan exemplary embodiment.

FIG. 16 is an exploded perspective view of a portion of the device ofFIG. 12, shown according to an exemplary embodiment.

FIG. 17 is a longitudinal cross-section view of the device taken alongline 17-17 of FIG. 1, shown according to an exemplary embodiment.

FIG. 18A is a radial cross-section view of the device taken along line18-18 of FIG. 1 in a deflated state, shown according to an exemplaryembodiment.

FIG. 18B is a radial cross-section view of the device taken along line18-18 of FIG. 1 but showing the device in an inflated state, accordingto an exemplary embodiment.

FIG. 19 is a schematic block diagram of the device of FIG. 12, shownaccording to an exemplary embodiment.

FIG. 20 is a schematic block diagram of the processing electronics ofthe device of FIG. 12, shown according to an exemplary embodiment.

FIG. 21 is a schematic flow chart of a process for toning pelvic floormuscles, shown according to an exemplary embodiment.

FIG. 22 is a schematic flow chart of a process for toning pelvic floormuscles, shown according to another exemplary embodiment.

FIG. 23 is a schematic sagittal cross-sectional view of a user with thedevice of FIG. 1 in an inserted position, shown according to anexemplary embodiment.

DETAILED DESCRIPTION

Referring generally to FIGS. 1-11 and 23, a medical device and method oftreatment are shown according to exemplary embodiments. According to theembodiments shown, the medical device 100 generally includes a handle110 and a probe 120, the probe 120 configured for insertion into avagina. The probe 120 includes an inflatable member or balloon 124 onthe outer surface of which at least one electrode 128 is disposed. Aninflation device may be located in the handle 110 and configured tocause the balloon 124 to inflate, in turn causing at least one of theelectrodes 128 to press against at least one vaginal wall. The balloon125 may be inflated to a plurality of different inflated positionsbetween fully deflated and fully inflated. A controller 104interconnected with the handle 110 includes processing electronics 800configured to control the electrodes 128 such that the electrodes 128cause a contraction of a muscle in communication with an electrode 128.

According to an exemplary embodiment, the device and method for treatingincontinence deliver electrical pulses to stimulate muscle contractionto strengthen the muscles in the area of the pelvic floor. Electricalstimulation causes muscles to contract and release repeatedly, therebystrengthening those muscles. Urinary incontinence in general, andurinary incontinence in females specifically, may be treated bystrengthening the muscles that are responsible for bladder control(e.g., the pelvic floor muscles) using internal electrical stimulation.While the method and device are described for the treatment of urinaryincontinence, it is contemplated that this device may also be used forother medical purposes, for example, bowel incontinence, in which casereferences to a vagina would correspondingly refer to an anus and/orrectum. Persons skilled in the art can also adapt the method and devicefor other internal applications through other natural orifices orthrough surgically created orifices.

Referring generally to FIGS. 12-23, a stimulation device for creating apleasurable sensation in a user and a method of toning pelvic floormuscles are shown according to exemplary embodiments. According to theembodiment shown, the device 101 includes a handle 111 and a probe 121,the probe 121 configured for insertion into a vagina. The probe 121includes an inflation member or balloon 125 having an outer surface 127.The balloon 125 may be configured to assume a plurality of states ofexpansion between minimum expansion and maximum expansion. According toone embodiment, a first electrode 129 a, a second electrode 129 b, and afirst vibrating element [shown as a Gräfenberg Spot (G-Spot) stimulator133] are disposed on the outer surface of the balloon 125. A secondvibrating element (shown as a clitoral stimulator 141) is shown disposedon the handle 111. An inflation device may be located in the handle 111and configured to cause the balloon 125 to inflate, in turn causing atleast one of the electrodes 129 to press into contact with at least onevaginal wall. Processing electronics 801 may be located in the handle111 and configured to control the current and voltage provided to theelectrodes 129 such that the electrodes 129 cause a contraction of amuscle in communication with an electrode 129. The processingelectronics 801 may also be configured to control at least one aspect ofone or more vibrating elements 133, 141.

According to one embodiment, devices and methods described for toningpelvic floor muscles deliver electrical pulses to stimulate musclecontraction to strengthen the muscles in the area of the pelvic floor.Electrical stimulation causes muscles to contract and releaserepeatedly, thereby strengthening those muscles. Toning and tighteningpelvic floor muscles improves intimate health and may increase the powerand intensity of the female orgasm. Electrical tissue stimulation mayalso provide a pleasurable sensation to the user. While the method anddevice are described for vaginal stimulation and pelvic floor toning, itis contemplated that this device may cause pleasurable sensations to auser or tone pelvic floor muscles via the anus and rectum, in whichcase, references to vagina would be modified accordingly.

Before discussing further details of the devices, it should be notedthat references to “front,” “rear,” “right,” and “left” in thisdescription are merely used to identify the various elements as they areoriented in the FIGURES, with “right,” “left,” “front,” and “rear” beingrelative to a specific direction. These terms are not meant to limit theelement which they describe, as the various elements may be orienteddifferently in various applications.

It should further be noted that for purposes of this disclosure, theterm coupled means the joining of two members directly or indirectly toone another. Such joining may be stationary in nature or moveable innature and/or such joining may allow for the flow of fluids,electricity, electrical signals, or other types of signals orcommunication between the two members. Such joining may be achieved withthe two members or the two members and any additional intermediatemembers being integrally formed as a single unitary body with oneanother or with the two members or the two members and any additionalintermediate members being attached to one another. Such joining may bepermanent in nature or alternatively may be removable or releasable innature.

Referring to FIG. 1, a perspective view of a device 100 is shownaccording to an exemplary embodiment. As described below, device 100 maybe used for the treatment of urinary incontinence, specifically inwomen. According to the exemplary embodiment shown, device 100 includesa probe assembly 102 which includes a housing, shown as handle 110, anda probe 120. Handle 110 provides the user a region which may be graspedfor control and manipulation of the probe assembly 102. Handle 110 mayfacilitate insertion, positioning, and removal of probe 120. Handle 110is shown to include a sleeve 112 configured to cover the majority ofhandle 110. Sleeve 112 is preferably pliable and provides a smooth andwatertight surface to handle 110. The smooth and watertight surfacefacilitates cleaning which is beneficial due to the handle's 110proximity to bodily fluids and the vaginal opening during use. Sleeve112 may be translucent to allow lights (e.g., lamps, LEDs, displays,etc.) within handle 110 to shine through. Further, sleeve 112 may becustomizable, e.g., bearing various colors or logos. Preferably, sleeve112 is formed from silicone rubber.

According to the embodiment shown, probe 120 generally has the form ofan elongated cylinder having an open proximal end and a closed distalend. Probe 120 may include a neck portion 122 near the proximal end.Probe 120 includes a member or expandable portion, shown as balloon 124.According to the exemplary embodiment, balloon 124 includes a singleinflatable balloon having an outer surface 126. According to alternateembodiments, the expandable portion may include a plurality of balloons.According to various embodiments, the plurality of balloons may beoriented axially, radially, circumferentially, or some combinationthereof. Balloon 124 may be formed of an airtight, elastic,biocompatible material, such as silicone rubber. According to alternateembodiments, balloon 124 may be formed of any suitable material.

Probe 120 is further shown to include at least one electrode 128, shownas electrode 128 a (e.g., first electrode, top electrode, etc.).Preferably, electrode 128 is mounted to outer surface 126 of balloon 124in such a manner that electrode 128 may come into contact with tissueadjacent to balloon 124 when probe 120 is in an inserted position.Referring briefly to FIG. 2, probe 120 may include a second electrode128 b (e.g., bottom electrode, etc.). First electrode 128 a and secondelectrode 128 b are shown radially opposite one another; however, probe120 may have a plurality of electrodes 128, the plurality of electrodesbeing located anywhere on probe 120, e.g., left and right sides, both ontop, axially or circumferentially offset, or equally or unequally spacedcircumferentially around probe 120. The relative position of theelectrodes 128 is dependent upon the particular tissue to receive theelectrical stimulation. The placement and relative spacing of theelectrodes will determine, in part, the effectiveness of the musclecontraction as a result of the electrical stimulation. According tovarious embodiments, a plurality of electrodes may be energized at thesame time, different electrodes (e.g., a subset of a plurality ofelectrodes) may be actuated during different phases of a treatmentsession, or different electrodes may be actuated during differenttreatment sessions. For example, an even number of electrodes 128 may beactuated in pairs, or an odd number of electrodes may be actuated in arotating pattern. Actuating different electrodes 128 at different timesmay cause different muscles to contract, thereby strengthening more anddifferent pelvic floor muscles and preventing the muscles from becomingadjusted or de-sensitized to the electrical stimulation. The pluralityof electrodes 128 may have the same or different shape. Electrode 128 isconfigured to deliver electrical pulses (e.g., signals, currents,voltages, frequencies, etc.) to stimulate muscle contraction tostrengthen the muscles in the area of the pelvic floor. Electrode 128may also communicate a response information (e.g., a signal indicativeof the contractive force of the muscles) to processing electronics.According to one embodiment, the response information is a voltagecreated by the contracting muscle. According to another embodiment, theresponse information is an electric potential difference between firstelectrode 128 a and second electrode 128 b. The muscle contractioncausing the response information may be caused by electrode stimulationof the muscle or may be the result of a manual contraction caused by theuser.

According to the exemplary embodiment, electrodes 128 may be formed fromstainless steel, and in another embodiment, the electrodes may be formedfrom an expandable, conductive silicone rubber or any other suitablematerial. It may be desirable to limit electrodes 128 from expanding soas to maintain a relatively consistent conductivity or to prevent themuscle stimulation from moving as balloon 124 is expanded. Further,electrodes formed of materials different than balloon 124 may not expandat the same rate as balloon 124 during inflation. Therefore, it may bebeneficial to provide a balloon 124 which expands non-uniformly.

According to the exemplary embodiment, electrode 128 a is supported by afirst portion of balloon 124. The first portion of balloon 124 and asecond portion of balloon 124 cooperate to cause balloon 124 to expandin a radially and/or circumferentially non-uniform manner relative toprobe 120. Similarly, electrode 128 b is supported by a third portion ofballoon 124. The first and third portions of balloon 124 cooperate tocause balloon 124 to expand in a radially and/or circumferentiallynon-uniform manner relative to probe 120. Non-uniform expansion ofballoon 124 may cause balloon 124 to substantially contour to theanatomy of a user, for example, to conform to the contours of the user'svagina. Non-uniform expansion of balloon 124 may also facilitate asuitable and comfortable fit of balloon 124 for the user.

According to one embodiment, the second portion may be an expansionportion (e.g., folds, pleats, articulation, etc.), shown as bellows 130.The folds of bellows 130 provide a region of increased surface area ofballoon 124 in the deflated state, which allows balloon 124 to expand ina circumferentially non-uniform manner. As shown, bellows 130 extendlongitudinally or axially along the sides of balloon 124. Bellows 130are further shown to extend around the distal end of balloon 124.Accordingly, bellows 130 are shown to extend substantially continuouslyaround the midsection (e.g. equatorially region) of balloon 124.According to various alternate embodiments, bellows 130 may extenddiscontinuously, in a top/bottom meridian formation, or in any suitableorientation to cause differential expansion of balloon 124. Probe 120may include any number of bellows 130 equally or unequally spaced aroundprobe 120. Referring briefly to FIGS. 5 and 6A, bellows 130 may beconfigured to provide an opening 602 through which wires 226 may passwhen balloon 124 is in a deflated state. According to the exemplaryembodiment, bellows 130 are configured such that a majority of theexpansion of balloon 124 occurs in the bellows region.

Referring now to FIG. 6A, a radial cross-section of probe 120 is shownin a first state (e.g., minimum expansion, contracted, deflated, etc.),whereas FIG. 6B shows a radial cross-section of probe 120 in a secondstate (e.g., expanded state, inflated, etc.). As seen in the first,deflated state, bellows 130, first and third portions of balloon 124 areclosely adjacent to or abut shaft 210. However, in the second, orexpanded state, bellows 130 have substantially unfolded allowing radialexpansion of the first and third portions of balloon 124 and electrodes128 a and 128 b provided thereon.

According to another embodiment, the first portion of balloon 124 mayhave a first thickness 604, and the second portion of balloon 124 mayhave a second thickness 606, specifically thickness 604 of the firstportion being greater than thickness 606 of the second portion.Accordingly, the first portion tends to resist circumferential expansionand maintain its form when balloon 124 is inflated. The second portionprovides a “path of least resistance” for expansion, such that for aprescribed level of inflation pressure, balloon 124 will stretch orexpand the material of balloon 124 more in the second region than in thefirst region.

According to one embodiment, at minimum expansion, balloon 124 has adiameter of between approximately 1 inch and approximately 2 inches.Preferably, at minimum expansion, balloon 124 has a diameter ofapproximately 1⅛ inches. According to one embodiment, at maximumexpansion, balloon 124 has a diameter of between approximately 2 inchesand approximately 4 inches, the preferred maximum expansion of balloon124 being between approximately 3 inches and approximately 4 inches indiameter. Expansion of balloon 124 in these ranges enables contouringballoon 124 to women of different anatomical sizes.

Returning to FIG. 1, probe assembly 102 may include a protrusion, shownas bump 132, located on a portion of probe 120. As shown, bump 132 islocated on a top portion of the outer surface of balloon 124. Bump 132may be used to indicate to a user that probe 120 is properly inserted.For example, bump 132 may provide a user a point of reference forinternal positioning probe 120. According to the exemplary embodiment,bump 132 may include a cavity 502 (shown in FIG. 5), which may beconfigured to receive a sensor (e.g., capacitive sensor, pressuresensor, conductivity sensor, etc.), which will be discussed furtherbelow.

According to the exemplary embodiment, an electronic control unit, shownas controller 104, is connected to handle 110 via cable 106. In theembodiment shown, controller 104 is a handheld control unit (i.e., onethat is sized to fit in the user's hand). Controller 104 includes apower supply 808, processing electronics 800, indicators (e.g., audio,visual, and/or haptic indicators), and input controls 704 which will bediscussed in detail below. According to alternate embodiments,communication between controller 104 and probe assembly 102 may bewireless, for example, using Bluetooth, wireless local area network, orpersonal area network protocols. According to various other embodiments,any or all of the components of controller 104 may be located on or inprobe assembly 102.

Referring to FIG. 2, a perspective view of a portion of probe assembly102 is shown with sleeve 112 and balloon 124 removed, according to anexemplary embodiment. Handle 110 may be formed of a plurality ofportions, such as a “clam shell” assembly. As shown, handle 110 includesa left portion 202, a right portion 204, and a bottom portion 206,wherein left portion 202 and right portion 204 are hollow, substantiallysymmetric pieces of ABS plastic coupled together to form a housing.Bottom portion 206 may include an inflation device, wherein bottomportion 206 is formed of a deformable material, for example, a siliconerubber which sufficiently pliable to compress the inflation device andto return to shape. According to various alternate embodiments, bottomportion 206 may be a rigid portion movably coupled to left portion 202and/or right portion 204. Left portion 202, right portion 204, andbottom portion 206 may be formed of any suitable material, may be formedof the same or different materials, or may be formed as one element.Portions of handle 110 may be coupled by snap fit, fastener, hinge,and/or any other suitable coupling technique. Handle 110 is furthershown to include a release valve 208, discussed in detail below.

According the exemplary embodiment seen in FIGS. 2 and 4-6B, probeassembly 102 includes a shaft 210. As shown, shaft 210 is an elongatedstructure having a distal end 212 and a proximal end 214. According tothe embodiment shown, proximal end 214 is coupled to handle 110 andinterconnected to controller 104 via cable 106. Shaft 210 may include anoperative region 216 located between proximal end 214 and distal end212, the operative region 216 being configured to be substantiallylocated within the vagina when probe 120 is in an inserted position.

As shown, shaft 210 includes a radially extending flange (e.g., collar),shown as bulkhead 218. Bulkhead 218 is configured to provide asubstantially airtight seal between handle 110 and balloon 124.According to the exemplary embodiment, bulkhead 218 includes a firstpassage, shown as bottom passage 220, and a second passage, shown as toppassage 224. Bottom passage 220 may be configured to allow a conduit,shown as tube 222, to extend from an inflation device into balloon 124.A substantially airtight seal is preferably formed (e.g., with siliconeglue) between tube 222 and bulkhead 218. Top passage 224 may beconfigured to allow wires 226 to pass from electrodes 128 and/or othersensors or motors into handle 110. A substantially airtight seal may beformed (e.g., with silicone glue) between wires 226 and bulkhead 218.Bulkhead 218 may have any number of passages, and the passages may haveany orientation around shaft 210. Alternatively, bulkhead 218 mayinclude one passage for passing both tube 222 and wires 226.

Shaft 210 may be solid, hollow, or any combination thereof. According toone embodiment, shaft 210 may be configured to house batteries used topower device 100 or components thereof. According to another embodiment,tube 222 and/or wires 226 may be routed through shaft 210. According toyet another embodiment, shaft 210 may include perforations configured toallow pressurizing fluid pumped through shaft 210 to enter into balloon124. Routing pressurizing fluid, tube 222, and/or wires 226 throughshaft 210 may eliminate the need for passages 220, 224 through bulkhead218. Accordingly, these passages may be removed in order to improve theairtight seal between handle 110 and balloon 124.

Referring to FIG. 3, a bottom view of device 100 is shown according toan exemplary embodiment. Handle 110 includes a coupling point 302configured to receive cable 106. Coupling point 302 may be a jack ororifice in handle 110. According to the exemplary embodiment, couplingpoint 302 is a cap forming an end portion of shaft 210 and configured toallow wires 226 to pass out of handle 110. Handle 110 is further shownto include structure such as air inlet 304 (or orifice, valve, grommet,etc.) for inflation of balloon 124 described further below.

The diameter of balloon 124 may be substantially uniform over the lengthof probe 120, or the diameter of balloon 124 may vary. As shown,proximal end 214 of balloon 124 has a first diameter, and distal end ofballoon 124 has a second diameter, the second diameter being greaterthan the first diameter. According to one embodiment, probe 120transitions from the first diameter to the second diameter between neckportion 122 and electrode 128. According to the embodiment shown inFIGS. 3 and 5, balloon 124 begins to transition from the first diameterto the second diameter proximate bump 132. Varying the diameter ofballoon 124 along the length of probe 120 effects the expansion ofballoon 124 along the length of probe 120. For example, the smallerproximal diameter limits expansion at proximal end 214 while allowinggreater expansion near of balloon 124 near electrodes 128 and proximalend 212, thereby contouring balloon 124 to the vaginal cavity. Thisfurther enables electrodes 128 to press against vaginal walls withoutapplying excessive pressure on the introitus (vaginal entrance).

Referring to FIG. 4, a partially exploded view of probe assembly 102 isshown with tube 222 and wires 226 removed for clarity, according to anexemplary embodiment. As shown, balloon 124 includes a depression,cavity, or pocket 402 configured to receive electrode 128. According toan exemplary embodiment, a periphery of electrode 128 is configured toseat into pocket 402, and a sealant (e.g., silicone glue) may be used tocouple electrode 128 to pocket 402 and to form a substantially airtightseal between electrode 128 and balloon 124. Forming a seal between anouter periphery of electrode 128 and balloon 124 achieves the addedbenefit of preventing fluid or debris from getting underneath electrode128, thereby facilitating sanitary maintenance of probe 120. Balloon 124is further shown to include an aperture, shown as hole 404, which isconfigured to permit passage of wires 226 from electrode 128 to theinterior of balloon 124. A sealant may be used to retain wires 226 inplace and to form a substantially airtight seal between wires 226 andballoon 124.

According to the embodiment shown, probe 120 comprises only one balloon124 configured to surround operative region 216 of shaft 210. Referringbriefly to FIG. 23, singular balloon 124 is shown to surround the entireportion of shaft 210 located within a vagina 21 when probe 120 is in aninserted position. According to various embodiments, probe 120 is in aninserted position when electrodes 128 are located within the vagina 21or when bump 132 is proximate a user's Gräfenberg Spot (G-Spot) 23. Useof a single balloon has the benefit of minimizing costs (assembly andmaterial) while also simplifying the structure of the device.

Referring to FIG. 5, a longitudinal cross-section of probe assembly 102is shown according to an exemplary embodiment. Balloon 124 is shown todefine a lumen or cavity 530, and cavity 530 is configured to receiveshaft 210. Balloon 124 is shown to circumferentially surround at least aportion of shaft 210.

Probe assembly 102 is shown to include an inflation device located atleast partially within bottom portion 206 of handle 110 for selectivelyinflating and deflating balloon 124. According to an exemplaryembodiment, the inflation device includes a pump 510 which may bemanually operated. Pump 510 includes a cavity within bottom portion 206,shown as bladder 512, and a first check valve 514 is located betweenbladder 512 and air inlet 304. Check valve 514 permits air to enterbladder 512 through air inlet 304 from outside of probe assembly 102 andprevents air from exiting back through air inlet 304 when bladder 512 iscompressed. A second check valve 516 is located between tee connector518 and bladder 512. Check valve 516 permits air to enter tee connector518 from bladder 512 and prevents air from back flowing into bladder512, for example, when bladder 512 expands.

As shown, tee connector 518 couples bladder 512, release valve 208, andtube 222. Release valve 208 may be of any suitable mechanism to permitair under pressure to be selectively released from balloon 124, forexample a thumbscrew or a pushbutton. Release valve 208 may also act asa relief valve to prevent over-pressurization of balloon 124. Tube 222extends from an outlet of tee connector 518 through bulkhead 218 intoprobe 120. In operation, squeezing bottom portion 206 compresses bladder512 and forces air through tee connector 518 and tube 222 into balloon124. When the squeezing force exerted on bladder 512 is released,bladder 512 will resume its natural, inflated position as air is drawninto bladder 512 through check valve 514. Bladder 512 is squeezed andreleased repeatedly to force pressurized air into balloon 124. Increasedpressure in balloon 124 eventually causes inflation of balloon 124,which in turn causes electrode 128 to contact a vaginal wall. Accordingto one embodiment, the level of inflation of balloon 124 is controlledby a user and may be selected to ensure a suitable and comfortable fitbetween balloon 124 and the user's vagina. According to anotherembodiment, the appropriate level of inflation is communicated to theuser by a health care professional. According to another embodiment, theappropriate level of inflation is stored in memory 920 of processingelectronics 800 described below. According to various alternateembodiments, the inflation device may include a motorized pump, theinflation device may be located in controller 104 and pressurized airdirected into balloon 124 through flexible tubing, and/or the inflationdevice may be located within probe 120. As described, the pressurizingfluid of the exemplary embodiment is air; however, any suitablepressurizing fluid may be used, for example, water, saline, oil, orother gases or liquids.

According to an exemplary embodiment, device 100 may include a pressuresensor 520, located in handle 110 and barometrically connected toballoon 124. According to one embodiment, a sampling tube extends fromthe interior of balloon 124 to pressure sensor 520. According to otherembodiments, a sampling tube may extend from tube 222 or tee connector518 to pressure sensor 520. According to other embodiments, pressuresensor 520 may be located in-line with tube 222, located in probe 120,for example in cavity 502, or located in controller 104. Pressure sensor520 may visually display an indication of pressure on handle 110, forexample, a gauge, a light, a digital display, etc. According to anexemplary embodiment, pressure sensor 520 is configured to communicate(via wires or wirelessly) pressure information to processing electronics800. For example, pressure sensor 520 may generate a responseinformation, e.g., a signal indicative of the contractive force of themuscles on balloon 124. The response information may correlate to a risein pressure created in balloon 124 by the contracting muscle acting onballoon 124. The response information may be triggered by the electricalstimulation provided by electrodes 128 or may be triggered by the usermanually (e.g., consciously, volitionally, voluntarily, etc.) forcing acontraction of her pelvic floor muscles.

According to an exemplary embodiment, neck portion 122 of probe 120includes an external annular groove 522 and an internal annular groove524. Internal annular groove 524 is configured to fit over a radialperiphery of bulkhead 218, and a sealant (e.g., silicone glue) may beused between internal annular groove 524 and bulkhead 218 to form asubstantially airtight seal. Proximate bulkhead 218, left handle portion202 and right handle portion 204 cooperate to form a substantiallycylindrical portion 526 and an inwardly extending annular flange 528.Substantially cylindrical portion 526 fits over neck portion 122 ofprobe 120 and helps to hold internal annular groove 524 against bulkhead218. Inwardly extending flange 528 fits into external annular groove 522of probe 120. Accordingly, neck portion 122 and handle 110 areconfigured to prevent balloon 124 from slipping free of handle 110.

Referring to FIGS. 6A and 6B, shaft 210 is shown to be axially locatedwithin cavity 530 of probe 120. According to the exemplary embodiment,shaft 210 is configured to provide sufficient rigidity to probe 120 tofacilitate insertion of probe 120 into a vagina. Shaft 210 may include aplurality of portions (e.g., members, structures, regions, webs, etc.),shown as ribs 610, configured to support balloon 124. Ribs 611 a maysupport bellows 130 and inhibit bellows 130 from collapsing into cavity530. Balloon 124 may include a plurality of structures (stiffeners,portions, etc.), shown as lugs 612, which are shown to rest on ribs 610b when balloon 124 is in a fully deflated state. Lugs 612 providecushioning between shaft 210 and a user. Lugs 612 may also stiffenportions of balloon 124 underneath electrodes 128, thereby reducingflexure of balloon 124 in the area of the electrode. As shown, bellows130, lugs 612 and ribs 610 are configured to cooperate to maintain asubstantially round shape to probe 120 when balloon 124 is in a deflatedstate.

Referring to FIG. 7, a front view of controller 104 is shown accordingto an exemplary embodiment. As shown, controller 104 may include ahousing 700, a front panel 702, and a cavity that receives one or morebatteries to supply power to device 100. Front panel 702 may include aplurality of control inputs (e.g. toggles, switches, an electro-acoustictransducer configured to receive voice commands, a touch sensitivedisplay, etc.), shown as buttons 704, configured to enable user inputinto controller 104. For example, button 704 a may be a power buttonconfigured to turn controller 104 on and off. Button 704 a may be acombination power/mode button configured to turn controller 104 on andoff and to switch between operating states. According to an exemplaryembodiment, buttons 704 b may provide other control inputs, for example,stimulation select, pressure select, increase, decrease, pause, etc.

According to the embodiment shown, front panel 702 includes a pluralityof sequentially oriented lamps 708 (e.g., lights, LEDs, etc.) configuredto indicate the level of stimulation intensity and/or pressure insideballoon 124. Controller 104 may also include a display 710 configured tonumerically indicate balloon pressure and/or stimulation intensity.Display 710 may be further configured to display videos, for exampleinstructional videos, or to display a waveform representative of thestimulation signal. Display 710 and the plurality of lamps 708 mayindicate the same or different information. Front panel 702 may includea plurality of indicator lamps 712 (e.g. lights, LEDs, etc.) which mayindicate a power state (e.g., power on, battery low, etc.), acommunication state (e.g., communication to a computer, to probeassembly 102, etc.), pressure state (e.g., the pressure inside balloon124 has reached a predetermined value), an error state, etc. Accordingto an alternate embodiment, controller 104 may include a touchscreenconfigured to both provide information to a user and to receive inputfrom a user. Using a touchscreen would provide an easy to clean surface,thereby facilitating sanitary hygiene.

Controller 104 may also include an audio device, shown as speaker 714.Speaker 714 may be configured to provide motivation and/or audioinstruction to a user. According to one embodiment, speaker 714 mayannounce that the pressure inside balloon 124 has reached a prescribedlevel. According to another embodiment, speaker 714 may request a userto force a contraction of the muscle in communication with electrodes128.

Referring again to FIG. 3, cable 106 is shown to couple to controller104 using connector 310. According to an exemplary embodiment, connector310 is a D-sub-9 connector. According to alternate embodiments, anysuitable connector may be used (e.g., a Universal Serial Bus connector).Cable 106 may be decoupled from controller 104, and controller 104 maythen be coupled to a computer to receive firmware (e.g., configurationdata) or protocol data updates from the computer. According to variousalternate embodiments, controller 104 may wirelessly connect to acomputer, controller 104 may include an interface which enables theprotocol to be entered directly into controller 104, or cable 106 isconfigured to remain coupled to controller 104 and to de-couple fromprobe assembly 102.

Operation of device 100 is described below according to an exemplaryembodiment. A method for treating urinary incontinence in a femaleincludes inserting probe 120 into the vagina, pressurizing balloon 124to inflate balloon 124 such that electrodes 128 contact the walls of thevagina (e.g., to place electrodes 128 snugly against the walls of thevagina to provide an electrical conduction pathway from the electrodesto the muscles and/or associated nerves), and periodically supplying apulsed electrical stimulation to electrodes 128 to stimulate themuscles. In this manner, balloon 124 allows device 100 to ensure aproper fit with differing anatomies. As the muscles contract in responseto the electrical stimulation, the muscle walls of the vagina exert aforce on inflated balloon 124, and as the muscles contract, balloon 124is compressed. Pressure sensor 520 generates a signal indicative of thecontractive force of the muscles on balloon 124 triggered by theelectrical stimulation provided through the electrodes 128. The signalfrom pressure sensor 520 may be communicated (e.g., via wired orwireless connections) to processing electronics 800. Processingelectronics 800 may be configured to process the signal from pressuresensor 520 to determine information related to muscle contraction causedby the electrical stimulation (e.g., the force or strength of musclecontraction, the duration of muscle contraction, etc.). When musclecontraction stops, the air pressure within balloon 124 causes balloon124 to expand to original inflated size. The method also includes usinga biphasic pulse. The progress of the treatment can be monitored byevaluating the increase in strength of muscle activity by measuringmuscle contraction over a number of treatment sessions. Urinaryincontinence in general, and urinary incontinence in femalesspecifically, may be treated by strengthening the muscles that areresponsible for bladder control (e.g., the pelvic floor muscles) usinginternal electrical stimulation. This treatment may be useful for womenwho have become incontinent with age or women who have becomeincontinent due to recent childbirth. According to one embodiment,device 100 may be used three weeks after childbirth.

According to the exemplary embodiment described, processing electronics800 supply a biphasic pulse of electrical current to electrodes 128which in turn stimulates contraction of the muscles. For example, thebiphasic pulse may have a first stimulation phase providing a pulse at12 hertz for 6 seconds followed by a first rest period having a durationof 6 seconds. A second stimulation phase providing a pulse at 25 hertzfor six seconds follows the first rest period, and a second rest periodhaving a duration of 6 seconds follows the second phase. The use of abiphasic pulse (e.g., a pulse having two stimulation periods havingdifferent frequencies) prevents the muscles from becoming adjusted orde-sensitized to the electrical stimulation. This sequence ofstimulation phases and rest phases repeats for a treatment period asnecessary. A typical treatment period is approximately 15 minutes. Inanother embodiment, a multiphasic pulse (e.g., a plurality of differentpulse durations and/or frequency between pulses) may be used. Withineach stimulation phase, a symmetric alternating current may be appliedto the muscle via electrodes 128 to reduce the effects ofelectrophoresis or cataphoresis on the muscle tissues. For example,applying a current of a positive first value for a first pulsewidth(e.g., 200 microseconds), applying no current for 40 microseconds, andthen applying a current of a negative first value for a first value(e.g., 200 microseconds) limits the migration of ions with the muscletissue. This pattern of alternating current pulsewidths may then berepeated at various frequencies (hertz), e.g., 12 hertz, 25 hertz, 50hertz, etc. Accordingly, the amount of time between the end of thenegative current until the beginning of the positive current depends onthe frequency. Placing a short rest period (e.g., 40 microseconds)between the bipolar phases may improve circuit reliability.

In other embodiments, other frequencies and/or durations for thestimulation phases and/or rest periods may be used. For example, in oneembodiment, the frequency delivered may be variable, and frequencies upto 50 hertz may be delivered. The current delivered during thestimulation phase may be substantially between 10 milliamps and 50milliamps. According to another embodiment, electronics 800 supply abiphasic pulse of electrical potential between electrodes 128. Theelectrical potential between electrodes 128 may be substantially between10 Volts and 50 Volts. It is believed that these ranges of current andvoltage provide therapeutic benefit. According to another embodiment,stimulation may occur as low as 4-5 Volts. Contraction of the muscle isa function of current (or voltage) amplitude, pulsewidth, and frequencyapplied to the muscle. Further, the rate at which the muscle relaxes hasa minimum persistence time that is affected by the strength and durationof the contraction. If the period (i.e., 1/frequency) of stimulation isgreater than the minimum persistence time of the contraction, a user mayperceive the stimulation as convulsions rather than a continuouscontraction. Accordingly, processing electronics 800 may be configuredto control one of frequency, pulsewidth, and amplitude in order tomaintain a contraction perceived by the user as substantiallycontinuous. According to one embodiment, processing electronics 800 maybe configured to control one of frequency, pulsewidth, and amplitudebased on the other two in order to maintain a substantially continuouscontraction. Additionally, processing electronics 800 may be configuredto ramp at least one of frequency, amplitude, and pulsewidth at thebeginning and/or end of each phase. Ramping the frequency, amplitude,and/or pulsewidth may reduce the step function of stimulation entering aphase, which may be uncomfortable or startling for some users. Accordingto one embodiment, the pulsewidth may be stepped up by a fraction of thedesired pulsewidth (e.g., 50 microseconds) per cycle until the desiredpulsewidth (e.g., 200 microseconds) is reached. Processing electronics800 may inhibit certain combinations of frequency, current, and voltage.According to the exemplary embodiment described, a health careprofessional may cause the stimulation parameters to be stored inprocessing electronics 800. In various alternate embodiments, the user,via a control 704 located on the controller 104, may control thefrequency of the electrical signal being supplied, may control thecurrent delivered during each stimulation phase, or may control thevoltage delivered during each stimulation phase.

According to an exemplary embodiment, protocol data 926 (e.g.,prescribed pressure, prescribed stimulation frequency, amplitude,pattern, etc.) may be stored into memory 920 in controller 104 by anon-user of probe 120 (e.g., a healthcare professional). Controller 104and probe assembly 102 may then be provided to the probe user (e.g., apatient); however, the probe assembly user cannot change the protocol.According to alternate embodiments, the probe user may change theprotocol, or the probe user may download a healthcare professionalprescribed protocol into memory 920 of controller 104.

Referring to FIG. 8, a block diagram of device 100 is shown according toan exemplary embodiment. Probe assembly 102 is shown to include a pump510, electrode 128, sensors 802, and vibration motor 804. Pump 510 isconfigured to cause inflation of balloon 124 and may be manuallyoperated or motorized. First electrode 128 a and/or second electrode 128b are configured to provide an electrical signal (e.g., current,voltage, frequency, etc.) to a muscle in communication with theelectrode. According to various embodiments, probe assembly 102 may haveone or a plurality of electrodes. Probe assembly 102 may include one ormore sensors 802 (e.g., a capacitive sensor, a pressure sensor 520, aconductivity sensor, etc.). Sensors 802 may be disposed in any suitablelocation in probe assembly 102 (e.g., in handle 110, in cavity 502 underbump 132, etc.). Vibration motors 804 may be configured to providehaptic feedback to a user in response to user input through controls 704or as an indication that balloon 124 has been inflated to apredetermined pressure. Alternatively, vibration motor 804 for may belocated in cavity 502 under bump 132 and configured to provide apleasurable sensation to a user. The pleasurable sensation may induce auser to maintain compliance with a prescribed treatment regimen. Thepleasurable sensation may be used to cause an orgasm, which in turncauses a release of serotonin and norepinephrine in the user which mayimprove the user's mood and treat depression, specifically post-partumdepression. In order to induce an orgasm, a clitoral stimulator (e.g.,clitoral stimulator 141 shown in FIG. 12) may be added to probe assembly102.

According to an exemplary embodiment, controller 104 includes controlinputs 704, lamps 708, 712, display 710, audio device 714, processingelectronics 800, probe assembly controller circuit 806, and power supply808. The control inputs may include any suitable user interface, e.g.,buttons 704, toggles, switches, an electro-acoustic transducerconfigured to receive voice commands, a touch sensitive display, etc.Lamps such as lamps 708, 712 may provide information to a user throughillumination, brightness, color, blinking pattern, and/or illuminationof a subset of a plurality of spatially oriented lamps. Display 710 mayalso be configured to provide alphanumeric or graphical images. Audiodevice 714 may be a speaker configured to provide aural information to auser and may be combined with or separate from the electro-acoustictransducer control input. Probe assembly controller circuit 806 is showncoupled to probe assembly 102 and may include any number of mechanicalor electrical circuitry components or modules for a pump 510, electrode128, sensors 802, and/or vibration motors 804 of probe assembly 102. Forexample, circuit 806 may be configured to send electrical signals topelvic floor muscles while sending response information to processingelectronics 800.

Controller 104 is further shown to include a power supply 808. Powersupply 808 is configured to provide electrical power to device 100 andcomponents thereof. According to an exemplary embodiment, device 100 isconfigured to be powered by a 6 Volt battery. According to otherembodiments, device 100 may use other voltages, a rechargeable battery,or may be plugged into utility power supply. Power supply 808 orprocessing electronics 800 may be configured to increase the voltageand/or amperage available to electrodes 128, for example, up to 110V.According to one embodiment, the maximum electrical potential generatedbetween the first electrode 128 a and second electrode 128 b isapproximately 80 Volts. According to another embodiment, it is believedthat the maximum therapeutic range of the electrical potential generatedbetween first electrode 128 a and second electrode 128 b isapproximately 50 Volts.

While the exemplary embodiment shows a separate probe assembly 102 andcontroller 104, it is contemplated that any or all of the componentsshown as part of controller 104 may be located in probe assembly 102.For example, lamps 708 and/or lamps 712 may be located on handle 110.Alternatively, control inputs 704, lamps 708, 712, display 710, audiodevice 714, processing electronics 800, and probe assembly controllercircuit 806 may be located in handle 110, and power supply 808 (e.g.,batteries) may be located in shaft 210. According to another embodiment,pump 510 may be located in controller 104.

Referring to FIG. 9, a detailed block diagram of processing electronics800 of FIG. 8 is shown, according to an exemplary embodiment. Processingelectronics 800 includes a processor 910 and a memory 920. According toan exemplary embodiment, processor 910 is configured to execute computercode stored in memory 920 to complete and facilitate the activitiesdescribed herein. For example, memory 920 is shown to include modules922-940 which are computer code modules (e.g., executable code, objectcode, source code, script code, machine code, etc.) configured forexecution by processor 910. When executed by processor 910, processingelectronics 800 is configured to complete the activities describedherein. Processing electronics includes hardware circuitry forsupporting the execution of the computer code of modules 922-940. Forexample, processing electronics 800 includes hardware interfaces (e.g.,output 950) for communicating control signals (e.g., analog, digital)from processing electronics 800 to circuit 806. Processing electronics800 may also include an input 955 for receiving, for example, sensordata from circuit 806, response information from circuit 806, userinputs from control inputs 704, or for receiving data or signals fromother systems or devices. According to various embodiments, processor910 may be or include one or more microprocessors, an applicationspecific integrated circuit (ASIC), a circuit containing one or moreprocessing components, a group of distributed processing components,circuitry for supporting a microprocessor, or other hardware configuredfor processing. Memory 920 can be any volatile or non-volatile memorydevice capable of storing data or computer code relating to theactivities described herein.

Memory 920 includes a memory buffer 922 for receiving sensor data, forexample response information, pressure data, voltage data, capacitivesensing data, conductivity data, etc. The sensor data may be stored inmemory buffer 922 until buffer 922 is accessed for data. For example, aprotocol module 928, electrode module 930, data logging module 932,conductivity module 934, inflation module 936, position module 938,pressure module 940, or another process that uses sensor data may accessbuffer 922. The sensor data stored in memory 920 may be stored accordingto a variety of schemes or formats. For example, the sensor data may bestored as streaming data, peak values, synchronous, asynchronous,separate buffers for each data type, one buffer for all sensor data, orany other suitable format for storing sensor information.

Memory 920 further includes configuration data 924. Configuration data924 includes data relating to device 100, such as electrode informationthat the electrode module 930 can interpret to determine how to commandthe electrodes 128 to cause a muscle contraction, for example the numberof electrodes, electrode conductivity, conductivity as a function ofexpansion or pressure, etc. According to another embodiment,configuration data 924 may include response information configurationdata which the protocol module 928 and/or data logging module 932 caninterpret to determine if response information will include anelectrical signal received from at least one of the electrodes 128, apressure signal received from a pressure sensor 520, or both. Accordingto another embodiment, configuration data 924 may include pumpinformation, such as whether the pump 510 is hand-operated or motorized,and control information of the motorized pump. According to anotherembodiment, configuration data 924 may include sensor information, suchas the existence, location, and calibration of pressure sensors 520,conductivity sensors, capacitive sensors, and the like.

Memory 920 further includes a protocol data 926 which includes datarelating to the treatment protocol. Protocol data 926 may include datathat protocol module 928 can interpret to determine how to command theelectrical signal sent to electrodes 128. For example, protocol data 926may include data relating to current, voltage, frequency, number ofphases of stimulation signal, duration and pattern of stimulationperiods, duration and pattern of rest periods, and/or duration oftreatment. Protocol data 926 may include data relating to apredetermined pressure (e.g., prescribed pressure, target pressure,threshold pressure, etc.) for balloon 124. Protocol data 926 may bestored in memory 920 by the user or another (e.g., a health careprofessional).

Memory 920 further includes a protocol module 928 which includes logicfor using configuration data 924, protocol data 926, sensor data fromthe memory buffer 922, and/or data received from another module to carryout the treatment protocol, e.g., providing stimulation commands toelectrode module 930. Protocol module 928 may output data to datalogging module 932 for recording, may cause outputs for providing anindication to a user, and may cause an output requesting a user toperform an activity (e.g., inserting probe 120, pressurizing balloon124, forcing a contraction, etc.). Protocol module 928 may include logicto cause closed-loop control of the electrical stimulation based onresponse information received from memory buffer 922, electrode module930, conductivity module 934, and/or pressure module 940.

Memory 920 further includes an electrode module 930 which includes logicfor causing a contraction of a muscle in communication with electrode128. Electrode module 930 may control the stimulation of a muscle incommunication with electrodes 128 based on conductivity informationreceived from conductivity module 934, position information receivedfrom position module 938, and/or pressure information received frompressure module 940. Electrode module 930 may include logic to controlthe current or voltage provided by electrodes 128 as a function offrequency, or to control the frequency in response to the current orvoltage. According to an exemplary embodiment, electrode module 930 mayinclude logic to use an 8-bit register to control the frequency,current, or voltage of the stimulation. Using an 8-bit register providesfine resolution for precise incontinence treatment.

Memory 920 further includes a data logging module 932 which includeslogic for causing a response information to be recorded. Data loggingmodule 932 may include logic for storing baseline information. Datalogging module 932 may record processed information or may record rawsensor information, may record data directly from protocol module 928,may record data from memory buffer 922 or another module, and/or mayrecord frequency and duration of use information. Recording frequencyand duration of use information may provide a record of whether apatient is adhering to a protocol and complying with a daily usage andtime regimen.

Memory 920 is shown to include a conductivity module 934 which includeslogic for determining the conductivity of the environment of probe 120,balloon 124, and/or electrodes 128. Conductivity of the environment isdependent on many factors. For example, conductivity may depend on theconductivity and quantity of artificial lubricants used, the quantity ofvaginal fluid present, which may change from day to day or during thetreatment protocol, and/or the expansion of electrodes 128. Conductivitymodule 934 may receive sensor data directly or through memory buffer922. Conductivity module 934 may provide conductivity information toelectrode module 930, data logging module 932, or any other modulerequiring conductivity information.

Memory 920 is shown to include an inflation module 936 which includeslogic for providing an indication to a user that the pressure insideballoon 124 has reached a predetermined value. According to oneembodiment, the predetermined value is a pressure stored in protocoldata 926. Inflation module 936 may use sensor data from memory buffer922 or pressure information from pressure module 940. Inflation module936 may include logic for causing inflation of balloon 124. For example,inflation module 936 may cause a request for a user to actuate pump 510or may cause actuation of a motorized pump 510. Inflation module 936 maycontrol pump 510 using configuration data 924 and pressure data receivedfrom memory buffer 922 or pressure module 940.

Memory 920 is shown to include a position module 938 which includeslogic for determining if probe 120 is inserted and/or properlypositioned. According to one embodiment, position module 938 may receivecapacitive sensor data from memory buffer 922. According to analternative embodiment, position module 938 may determine insertion ofprobe 120 from a change in continuity or a change in resistance betweenelectrodes 128. According to another alternative embodiment, positionmodule 938 may request user confirmation that probe 120 and/or balloon124 are inserted, for example, by providing input via control inputs 704on controller 104. Position module 938 may cause output from electrodemodule 930 to be inhibited if position module 938 determines thatballoon 124 has been removed from the vagina. For example, positionmodule 938 may cause electrodes 128 to stop providing an electricsignal, or position module 938 may provide position information toprotocol module 928 or to electrode module 930.

Memory 920 further includes a pressure module 940 which includes logicfor determining the pressure inside balloon 124. Pressure module 940 mayuse configuration data 924, pressure data received directly frompressure sensor 520, or pressure data received from memory buffer 922.Pressure module 940 may provide pressure information to inflation module936 and protocol module 928. Pressure module 940 may provide pressureinformation to electrode module 930, or may inhibit processingelectronics 800 from causing a contraction of the muscle if the pressurein balloon 124 is below a threshold value, e.g., balloon 124 has notbeen sufficiently inflated. Pressure module 940 may receive responseinformation from pressure sensor 520.

Referring to FIG. 10, a flowchart of a process 1000 for treating urinaryincontinence is shown according to an exemplary embodiment. Process 1000is shown to include the steps of providing a device as described aboveand including an expandable portion having an outer surface, a firstelectrode, and a second electrode (step 1002). Process 1000 furtherincludes the steps of inserting the uninflated probe in a vaginal cavity(step 1004), causing the expandable portion to inflate such that thefirst and second electrodes contact vaginal walls (step 1006), andcausing a contraction of the muscle in communication with the electrodes(step 1008). Process 1000 further includes deflating the expandableportion (step 1010) and removing the probe from the vaginal cavity (step1012). According to one embodiment, the first and second electrodescouple to the outer surface of the expandable portion and are configuredto cause a contraction of a muscle and communication with theelectrodes.

Referring to FIG. 11, a flowchart of process 1100 for treating urinaryincontinence is shown according to an exemplary embodiment. Process 1100is shown to include the steps of providing a device as described aboveand including a balloon having an outer surface, a first electrode, anda second electrode (step 1102). Process 1100 further includes the stepof requesting insertion of the balloon into a vaginal cavity (step1104), for example, by indicating that device 100 is initialized andready for insertion (e.g., illuminating in indicator lamp 712),providing an aural request through speaker 714, or providinginstructions along with providing probe assembly 102. The determinationof insertion may be an inference by processing electronics 800 (e.g., byposition module 938) or by a confirmation from a user through controlinputs 704. If the balloon is not inserted (step 1106) then process 1100returns to step 1104. According to an alternate embodiment, if theballoon is not inserted, then step 1106 may return to itself waiting fordetermination that the balloon has been inserted (e.g., dwelling).

If the balloon has been inserted (step 1106), process 1100 causesinflation of the balloon such that at least one of the first and secondelectrodes press against at least one vaginal wall (step 1108).According to various embodiments, step 1108 may include requesting auser to actuate pump 510, causing actuation of pump 510, and/or causingoperation of a motorized pump. If the pressure inside the balloon hasnot reached a predetermined value (step 1110) then process 1100 returnsto step 1108. Alternatively, if the pressure inside the balloon has notreached a predetermined value within a threshold time, process 1100 mayproceed to an error process (not shown) which may cause an indication oferror. If the pressure inside the balloon has reached a predeterminedvalue (step 1110), then process 1100 causes an indication that theballoon has been inflated to a pressure equal to or greater than apredetermined value (step 1112). According to various embodiments theindication may be visual, aural, or haptic. Process 1100 may furtherinclude the step of determining the conductivity of the environment ofthe electrode (step 1114). For example, a conductivity sensor in probe120 may determine the effects of vaginal fluids or lubricants have onthe conductivity of the probe environment. The conductivity sensor maymeasure the resistivity between electrodes 128 or measure the currentdelivered for a provided voltage. According to one embodiment, a lowvoltage (e.g., 2 Volts) is provided across electrodes 128, the resultingcurrent is measured, and resistance is calculated.

Process 1100 is further shown to include the steps of causing acontraction of a muscle in communication with the electrodes (step 1116)and causing a baseline information to be recorded (step 1118). Baselineinformation may be information from sensors 802 measured at a point intime after the balloon has been inserted and the pressure in the balloonhas reached a threshold value and no current or voltage is passingthrough electrodes 128. Process 1100 is further shown to include thesteps of requesting a user to manually or volitionally force acontraction of a muscle in communication with at least one of theelectrodes (step 1120) and causing a response information to be recorded(step 1122). Steps 1120 and 1122 enable tracking of the user's progress.The recorded data may be provided to a healthcare professional orreviewed by the user. Providing data to a healthcare professional mayinclude reviewing data directly from display 710 on controller 104,uploading the data from controller 104 to a computer, or transmittingthe response information across the Internet to a computer (e.g., aserver).

Various alternate embodiments of the process described are contemplated.For example, the order of steps may be changed, e.g., determining if theballoon is inserted (step 1106) may be a prerequisite to, or occursimultaneously with, determining the conductivity of the environment ofthe electrode (step 1114). According to another embodiment, causing abaseline information to be recorded (step 1118) may occur before causinga contraction of the muscle in communication with the electrodes (step1116). Process 1100 may not include all of the steps listed. Forexample, process 1100 may not include the steps of requesting insertionof the balloon into a vagina (step 1104) or determining if the balloonhas been inserted (step 1106). According to another embodiment, process1100 does not include the step of determining the conductivity of theenvironment of the electrode (step 1114). According to various otherembodiments, process 1100 may not include the steps of causing abaseline information be recorded (step 1118), requesting a user to forcea contraction of a muscle in communication with at least one of theelectrodes (step 1120), or causing a response information to be recorded(step 1122). Process 1100 may include additional steps, e.g.,lubricating the balloon, inserting the uninflated balloon in a vaginalcavity, deflating the balloon, and/or removing the balloon from thevaginal cavity.

According to another embodiment, process 1100 may output an indicationof the response information, for example, a outputting a valuecorresponding to the strength of the force contraction by illuminating aportion of the sequential lamps 708, displaying a pressure, and/ordisplaying a normalized strength value, e.g., on a 1-10 scale.

Referring to FIG. 12, a perspective view of a device 101 is shownaccording to an exemplary embodiment. As described below, device 101 maybe used for causing a pleasurable sensation or toning pelvic floormuscles, specifically in women. According to the exemplary embodimentshown, device 101 includes a housing, shown as handle 111, and a probe121. Handle 111 provides the user a region which may be grasped forcontrol and manipulation of the device 101 and to facilitate insertion,positioning, and removal of probe 121. Handle 111 is shown to include asleeve 113 configured to cover the majority of handle 111. Sleeve 113 ispreferably pliable and provides a smooth and watertight surface tohandle 111 wherein the smooth and watertight surface facilitatescleaning which is beneficial due to the handle's 111 proximity to bodilyfluids and the vaginal opening during use. Sleeve 113 may also betranslucent to allow lights 172, 178 (e.g., lamps, LEDs, displays, etc.)or a display (not shown) on handle 111 to shine through. Sleeve 113allows actuation of control inputs, shown as buttons 174, located belowsleeve 113. Further, sleeve 113 may be customizable, e.g., bearingvarious colors or logos. Preferably, sleeve 113 is formed from siliconerubber.

According to the exemplary embodiment, handle 111 includes a firstportion, shown as interface 115, which includes a plurality of controlinputs (e.g. toggles, switches, an electro-acoustic transducerconfigured to receive voice commands, a touch sensitive display, etc.),shown as buttons 174, configured to enable user input into device 101.For example, button 174 a may be a power button configured to turndevice 101 on and off. Button 174 a may be a combination power/modebutton configured to turn device 101 on and off and to switch betweenoperating states (e.g., vibrational patterns, pleasurable sensationversus muscle toning, etc.). According to the exemplary embodiment,buttons 174 b control the frequency or speed of vibration, and buttons174 c increase or decrease the intensity of the electrical stimulation.According to an alternate embodiments, buttons 174 may provide othercontrol inputs, for example, stimulation select, pressure select,increase, decrease, frequency, amplitude, current, voltage, pause, etc.

According to the embodiment shown, interface 115 includes a plurality ofsequentially oriented lamps 178 (e.g., lights, LEDs, etc.) configured toindicate the level of electrical stimulation intensity. According toother embodiments, lamps 178 may indicate a level of vibrationalintensity or the pressure inside balloon 125. Interface 115 may alsoinclude a display (not shown) configured to numerically indicate balloonpressure, stimulation intensity, or vibrational intensity. The displaymay be further configured to display images, pictures, or videos (e.g.,instructional or erotic images), or to display a waveform representativeof the stimulation signal. The display and the plurality of lamps 178may indicate the same or different information. Interface 115 mayinclude a plurality of indicator lamps 172 (e.g. lights, LEDs, etc.)which may indicate a power state (e.g., power on, battery low, etc.), acommunication state (e.g., communication to a computer, etc.), pressurestate (e.g., the pressure inside balloon 125 has reached a predeterminedvalue), an error state, etc.

According to an alternate embodiment, interface 115 may be located on aseparate control unit. The control unit may be coupled to handle 111 viacable 106 or configured to communicate with device 101 wirelessly, forexample, using Bluetooth, wireless local area network, or personal areanetwork protocols. According to various alternate embodiments, any orall of the components of device 101 may be located on or in the controlunit. For example, lamps 172, 178, control inputs 174, and/or powersupply 809 (e.g., batteries) may be located on the control unit.Alternatively, display 811, audio device 813, processing electronics801, and probe controller circuit 807 may be located in the controlunit. According to another embodiment, pump 511 may be located incontroller 104.

According to the embodiment shown, probe 121 generally has the form ofan elongated cylinder having an open proximal end and a closed distalend. Probe 121 may include a neck portion 123 near the proximal end.Probe 121 includes a member or expandable portion, shown as balloon 125.According to the exemplary embodiment, balloon 125 includes a singleinflatable balloon having an outer surface 127. According to alternateembodiments, the expandable portion may include a plurality of balloons.According to various embodiments, the plurality of balloons may beoriented axially, radially, circumferentially, or some combinationthereof. Balloon 125 may be formed of an airtight, elastic,biocompatible material, such as silicone rubber. According to alternateembodiments, balloon 125 may be formed of any suitable material.

Probe 121 is further shown to include at least one electrode 129, shownas electrode 129 a (e.g., first electrode, top electrode, etc.).Preferably, electrode 129 is mounted to outer surface 127 of balloon 125in such a manner that electrode 129 may come into contact with tissueadjacent to balloon 125 when probe 121 is in an inserted position.Referring briefly to FIG. 13, probe 121 may include a second electrode129 b (e.g., bottom electrode, etc.). First electrode 129 a and secondelectrode 129 b are shown radially opposite one another; however, probe121 may have a plurality of electrodes 129, the plurality of electrodesbeing located anywhere on probe 121, e.g., left and right sides, both ontop, axially or circumferentially offset, or equally or unequally spacedcircumferentially around probe 121. The relative position of theelectrodes 129 is dependent upon the particular tissue to receive theelectrical stimulation. The placement and relative spacing of theelectrodes will determine, in part, the effectiveness of the musclecontraction as a result of the electrical stimulation. According tovarious embodiments, a plurality of electrodes 129 may be energized atthe same time, different electrodes (e.g., a subset of a plurality ofelectrodes) may be actuated during different phases of an exercise orpleasurable sensation session, or different electrodes may be actuatedduring different sessions. For example, an even number of electrodes 129may be actuated in pairs, or an odd number of electrodes may be actuatedin a rotating pattern. Actuating different electrodes 129 at differenttimes may cause different muscles to contract, thereby toning more anddifferent pelvic floor muscles and preventing the muscles from becomingadjusted or de-sensitized to the electrical stimulation. According tovarious embodiments, a user may select which electrodes 129 are actuatedor may select a pattern or actuation of electrodes in order to provide adesired pleasurable sensation. Alternatively, position of electrodes 129may be chosen to facilitate manufacture of balloon 125, for example,aligning electrodes 129 with G-Spot stimulator 133 may simplify molddesign. The plurality of electrodes 129 may have the same or differentshape. Electrode 129 is configured to deliver electrical pulses (e.g.,signals, currents, voltages, frequencies, etc.) to stimulate musclecontraction to strengthen the muscles in the area of the pelvic floor.It is contemplated that the electrical stimulation provided to tonepelvic floor muscles may be different than the optimal stimulation toprovide a pleasurable sensation. Electrode 129 may also communicate aresponse information (e.g., a signal indicative of the contractive forceof the muscles) to processing electronics 801. According to oneembodiment, the response information is a voltage created by thecontracting muscle. According to another embodiment, the responseinformation is an electric potential difference between first electrode129 a and second electrode 129 b. The muscle contraction causing theresponse information may be caused by electrode stimulation of themuscle or may be the result of a manual contraction caused by the user.

According to the exemplary embodiment, electrodes 129 may be formed fromstainless steel, and in another embodiment, the electrodes may be formedfrom an expandable, conductive silicone rubber or any other suitablematerial. It may be desirable to limit electrodes 129 from expanding soas to maintain a relatively consistent conductivity or to prevent themuscle stimulation from moving as balloon 125 is expanded. Further,electrodes formed of materials different than balloon 125 may not expandat the same rate as balloon 125 during inflation. Therefore, it may bebeneficial to provide a balloon 125 which expands non-uniformly.

According to the exemplary embodiment, electrode 129 a is supported by afirst portion of balloon 125. The first portion of balloon 125 and asecond portion of balloon 125 cooperate to cause balloon 125 to expandin a radially and/or circumferentially non-uniform manner relative toprobe 121. Similarly, electrode 129 b is supported by a third portion ofballoon 125. The first and third portions of balloon 125 cooperate tocause balloon 125 to expand in a radially and/or circumferentiallynon-uniform manner relative to probe 121. Non-uniform expansion ofballoon 125 may cause balloon 125 to substantially contour to theanatomy of a user, for example, to conform to the contours of the user'svagina. Non-uniform expansion of balloon 125 may also facilitate asuitable and comfortable fit of balloon 125 for the user.

According to one embodiment, the second portion may be an expansionportion (e.g., folds, pleats, articulation, etc.), shown as bellows 131.The folds of bellows 131 provide a region of increased surface area ofballoon 125 in the deflated state, which allows balloon 125 to expand ina circumferentially non-uniform manner. As shown, bellows 131 extendlongitudinally or axially along the sides of balloon 125. Bellows 131are further shown to extend around the distal end of balloon 125.Accordingly, bellows 131 are shown to extend substantially continuouslyaround the midsection (e.g. equatorially region) of balloon 125.According to various alternate embodiments, bellows 131 may extenddiscontinuously, in a top/bottom meridian formation, or in any suitableorientation to cause differential expansion of balloon 125. Probe 121may include any number of bellows 131 equally or unequally spaced aroundprobe 121. Referring briefly to FIGS. 17 and 18A, bellows 131 may beconfigured to provide an opening 603 through which wires 227 may passwhen balloon 125 is in a deflated state. According to the exemplaryembodiment, bellows 131 are configured such that a majority of theexpansion of balloon 125 occurs in the bellows region.

Referring now to FIG. 18A, a radial cross-section of probe 121 is shownin a first state (e.g., minimum expansion, contracted, deflated, etc.),whereas FIG. 18B shows a radial cross-section of probe 121 in a secondstate (e.g., expanded state, inflated, etc.). As seen in the first,deflated state, bellows 131, first and third portions of balloon 125 areclosely adjacent to or abut shaft 211. However, in the second, orexpanded state, bellows 131 have substantially unfolded allowing radialexpansion of the first and third portions of balloon 125 and electrodes129 a and 129 b provided thereon.

According to another embodiment, the first portion of balloon 125 mayhave a first thickness 605, and the second portion of balloon 125 mayhave a second thickness 607, specifically thickness 605 of the firstportion being greater than thickness 607 of the second portion.Accordingly, the first portion tends to resist circumferential expansionand maintain its form when balloon 125 is inflated. The second portionprovides a “path of least resistance” for expansion, such that for aprescribed level of inflation pressure, balloon 125 will stretch orexpand the material of balloon 125 more in the second region than in thefirst region.

According to one embodiment, at minimum expansion, balloon 125 has adiameter of between approximately 1 inch and approximately 2 inches.Preferably, at minimum expansion, balloon 125 has a diameter ofapproximately 1⅛ inches. According to one embodiment, at maximumexpansion, balloon 125 has a diameter of between approximately 2 inchesand approximately 4 inches, the preferred maximum expansion of balloon125 being between approximately 3 inches and approximately 4 inches indiameter. Expansion of balloon 125 in these ranges enables contouringballoon 125 to women of different anatomical sizes.

Referring to FIGS. 12, 13, and 17, device 101 is shown to have a firstvibrating element, shown as a Gräfenberg Spot or G-Spot stimulator 133,and a second vibrating element, shown as a clitoral stimulator 141.Clitoral stimulator 141 is in the shape of a curved projection or fingerwhich extends outwardly from the outer surface 127 of balloon 125adjacent neck 123 of balloon 125. As shown in the figures, theprojection curves in the distal direction (i.e., away from neck 123 ofballoon 125). G-Spot stimulator 133 is shown as a rounded projection or“bump.” G-Spot stimulator 133 extends a shorter distance outwardly fromthe surface of balloon 125 than clitoral stimulator 141 such that theheight of clitoral stimulator 141 is greater than the height of G-Spotstimulator 133. G-Spot stimulator 133 is located between distal end 213of balloon 125 and clitoral stimulator 141, and clitoral stimulator 141is located between G-Spot stimulator 133 and the proximal end of theballoon. G-Spot stimulator 133 may be used to indicate to a user thatprobe 121 is properly inserted. For example, G-Spot stimulator 133 mayprovide a user a point of reference for internal positioning probe 121.

In the exemplary embodiment shown, G-Spot stimulator 133 includes acavity 503 and clitoral stimulator 141 includes a cavity 535. Cavities503 and 535 are configured to receive vibration actuators 533 and 537,respectively, which are configured to cause vibration of the associatedstimulator. According to an alternate embodiment, cavities 503 and 537may be configured to receive a sensor (e.g., capacitive sensor, pressuresensor, conductivity sensor, etc.), which will be discussed furtherbelow. In another embodiment, electrodes 129 may be positioned along theouter surfaces of G-Spot stimulator 133 and clitoral stimulator 141. Inanother embodiment, device 101 may include a single actuator thatgenerates vibrations which are transmitted to balloon 125, G-Spotstimulator 133 and clitoral stimulator 141.

The first vibrating element is shown coupled or mounted just below theouter surface 127 of balloon 125 near proximal end 215 of balloon 125.Thus, in this embodiment, the material that forms the outer surfaces ofthe first vibrating element is integral or continuous with the materialof balloon 125. The second vibrating element is shown coupled or mountedto flange 201 on handle 111 and is discontinuous with the material ofballoon 125. The material of balloon 125 and the outer surfaces of thefirst and second vibrating elements may be any stretchable or expandablebiocompatible material, and in one embodiment may be silicone rubber.

Referring to FIG. 13, a perspective view of a portion of device 101 isshown with sleeve 113 and balloon 125 removed, according to an exemplaryembodiment. Handle 111 may be formed of a plurality of portions, such asa “clam shell” assembly. As shown, handle 111 includes a left portion203, a right portion 205, and a bottom portion 207, wherein left portion203 and right portion 205 are hollow, substantially symmetric pieces ofABS plastic coupled together to form a housing. In the embodiment shown,left portion 203 and right portion 205 form a structure (e.g., base,support, etc.), shown as flange 201 which is configured to supportclitoral stimulator 141 and to form a passage through which wires 227 cmay pass into handle 111. Bottom portion 207 may include an inflationdevice, wherein bottom portion 207 is formed of a deformable material,for example, a silicone rubber which is sufficiently pliable to compressthe inflation device and to return to shape. According to variousalternate embodiments, bottom portion 207 may be a rigid portion movablycoupled to left portion 203 and/or right portion 205. Left portion 203,right portion 205, and bottom portion 207 may be formed of any suitablematerial, may be formed of the same or different materials, or may beformed as one element. Portions of handle 111 may be coupled by snapfit, fastener, hinge, and/or any other suitable coupling technique.Handle 111 is further shown to include a release valve 209, discussed indetail below, and a plurality of holes 271 configured to receive buttons174 and lamps 172, 178.

According the exemplary embodiment seen in FIGS. 13 and 16-18B, device101 includes a shaft 211 configured to house batteries used to powerdevice 101 or components thereof. As shown, shaft 211 is an elongatedstructure having a distal end 213 and a proximal end 215, the proximalend 215 being coupled to handle 111. According to an alternateembodiment, shaft 211 may be interconnected to a remote control unit viaa cable. Shaft 211 may include an operative region 217 located betweenproximal end 215 and distal end 213, the operative region 217 beingconfigured to be substantially located within the vagina when probe 121is in an inserted position. Shaft 211 may be solid, hollow, or anycombination thereof.

As shown, shaft 211 includes a radially extending flange (e.g., collar),shown as bulkhead 219. Bulkhead 219 is configured to provide asubstantially airtight seal between handle 111 and balloon 125.According to the exemplary embodiment, bulkhead 219 includes a firstpassage, shown as bottom passage 221, and a second passage, shown as toppassage 225. Bottom passage 221 may be configured to allow a conduit,shown as tube 223, to extend from an inflation device into balloon 125.A substantially airtight seal is preferably formed (e.g., with siliconeglue) between tube 223 and bulkhead 219. Top passage 225 may beconfigured to allow wires 227 to pass from electrodes 129 and/or othersensors or motors into handle 111. As shown, wires 227 a couple toelectrodes 129, and wires 227 b couple to G-Spot vibration actuator 533.A substantially airtight seal may be formed (e.g., with silicone glue)between wires 227 and bulkhead 219. Bulkhead 219 may have any number ofpassages, and the passages may have any orientation around shaft 211.Alternatively, bulkhead 219 may include one passage for passing bothtube 223 and wires 227.

According to alternate embodiments, tube 223 and/or wires 227 may berouted through shaft 211. Shaft 211 may include perforations configuredto allow pressurizing fluid pumped through shaft 211 to enter intoballoon 125. Routing pressurizing fluid, tube 223, and/or wires 227through shaft 211 may eliminate the need for passages 221, 225 throughbulkhead 219. Accordingly, these passages may be removed in order toimprove the airtight seal between handle 111 and balloon 125.

Referring to FIGS. 14 and 15, a bottom view and a top view,respectively, of device 101 are shown according to an exemplaryembodiment. Handle 111 includes a battery cap 303 configured to retainbatteries 541 within shaft 211. As shown, battery cap 303 cap forms anend portion of shaft 211. According to alternate embodiments, batterycap 303 may be configured to allow wires 227 to pass out of handle 111,for example, to a power outlet or to a remote control unit. Handle 111is further shown to include structure such as air inlet 305 (or orifice,valve, grommet, etc.) for inflation of balloon 125 described furtherbelow.

The diameter of balloon 125 may be substantially uniform over the lengthof probe 121, or the diameter of balloon 125 may vary. As shown,proximal end 215 of balloon 125 has a first diameter, and distal end ofballoon 125 has a second diameter, the second diameter being greaterthan the first diameter. According to one embodiment, probe 121transitions from the first diameter to the second diameter between neckportion 123 and electrode 129. According to the embodiment shown inFIGS. 3 and 5, balloon 125 begins to transition from the first diameterto the second diameter proximate G-Spot stimulator 133. Varying thediameter of balloon 125 along the length of probe 121 effects theexpansion of balloon 125 along the length of probe 121. For example, thesmaller proximal diameter limits expansion at proximal end 215 whileallowing greater expansion of balloon 125 near electrodes 129 andproximal end 212, thereby contouring balloon 125 to the vaginal cavity.This further enables electrodes 129 to press against vaginal wallswithout applying excessive pressure on the introitus (vaginal entrance).

Referring to FIG. 16, a partially exploded view of device 101 is shownwith tube 223 and wires 227 removed for clarity, according to anexemplary embodiment. As shown, balloon 125 includes a depression,cavity, or pocket 403 configured to receive electrode 129. According toan exemplary embodiment, a periphery of electrode 129 is configured toseat into pocket 403, and a sealant (e.g., silicone glue) may be used tocouple electrode 129 to pocket 403 and to form a substantially airtightseal between electrode 129 and balloon 125. Forming a seal between anouter periphery of electrode 129 and balloon 125 achieves the addedbenefit of preventing fluid or debris from getting underneath electrode129, thereby facilitating sanitary maintenance of probe 121. Balloon 125is further shown to include an aperture, shown as hole 405, which isconfigured to permit passage of wires 227 from electrode 129 to theinterior of balloon 125. A sealant may be used to retain wires 227 inplace and to form a substantially airtight seal between wires 227 andballoon 125.

According to the embodiment shown, probe 121 comprises only one balloon125 configured to surround operative region 217 of shaft 211. Referringbriefly to FIG. 23, singular balloon 125 is shown to surround the entireportion of shaft 211 located within a vagina 21 when probe 121 is in aninserted position. FIG. 23 schematically depicts the embodiment of thedevice depicted and generally described in relation to FIGS. 1-11.However, it is to be understood that the embodiment of the devicedepicted and generally described in relation to FIGS. 12-22 would besimilarly situated when in use. One key difference is that the vibrationelement 141 would extend to a point in which it abuts or is in contactwith the clitoris or the surrounding tissue. According to variousembodiments, probe 121 is in an inserted position when electrodes 129are located within the vagina 21 or when G-Spot stimulator 133 isproximate a user's Gräfenberg Spot (G-Spot) 23. Use of a single balloonhas the benefit of minimizing costs (assembly and material) while alsosimplifying the structure of the device.

According to the exemplary embodiment, device 101 includes a printedcircuit board 407 configured to be supported by left portion 203 andright portion 205 of handle 111. As shown, circuit board 407 isconfigured to support lamps 172, 178, input controls 174, and processingelectronic 801. A power supply 809 may be coupled to circuit board 407and batteries 541.

Referring to FIG. 17, a longitudinal cross-section of device 101 isshown according to an exemplary embodiment. Balloon 125 is shown todefine a lumen or cavity 531, and cavity 531 is configured to receiveshaft 211. Balloon 125 is shown to circumferentially surround at least aportion of shaft 211.

Probe assembly 102 is shown to include an inflation device located atleast partially within bottom portion 207 of handle 111 for selectivelyinflating and deflating balloon 125. According to an exemplaryembodiment, the inflation device includes a pump 511 which may bemanually operated. Pump 511 includes a cavity within bottom portion 207,shown as bladder 513, and a first check valve 515 is located betweenbladder 513 and air inlet 305. Check valve 515 permits air to enterbladder 513 through air inlet 305 from outside of device 101 andprevents air from exiting back through air inlet 305 when bladder 513 iscompressed. A second check valve 517 is located between tee connector519 and bladder 513. Check valve 517 permits air to enter tee connector519 from bladder 513 and prevents air from back flowing into bladder513, for example, when bladder 513 expands.

As shown, tee connector 519 couples bladder 513, release valve 209, andtube 223. Release valve 209 may be of any suitable mechanism to permitair under pressure to be selectively released from balloon 125, forexample a thumbscrew or a pushbutton. Release valve 209 may also act asa relief valve to prevent over-pressurization of balloon 125. Tube 223extends from an outlet of tee connector 519 through bulkhead 219 intoprobe 121. In operation, squeezing bottom portion 207 compresses bladder513 and forces air through tee connector 519 and tube 223 into balloon125. When the squeezing force exerted on bladder 513 is released,bladder 513 will resume its natural, inflated position as air is drawninto bladder 513 through check valve 515. Bladder 513 is squeezed andreleased repeatedly to force pressurized air into balloon 125. Increasedpressure in balloon 125 eventually causes inflation of balloon 125,which in turn causes electrode 129 to contact a vaginal wall. Accordingto one embodiment, the level of inflation of balloon 125 is controlledby a user and may be selected to ensure a suitable and comfortable fitbetween balloon 125 and the user's vagina. According to anotherembodiment, the preferred level of inflation is stored in memory 921 ofprocessing electronics 801 described below. According to variousalternate embodiments, the inflation device may include a motorizedpump, the inflation device may be located in a remote control unit andpressurized air directed into balloon 125 through flexible tubing,and/or the inflation device may be located within probe 121. Asdescribed, the pressurizing fluid of the exemplary embodiment is air;however, any suitable pressurizing fluid may be used, for example,water, saline, oil, or other gases or liquids.

According to various alternate embodiments, device 101 includes apressure sensor barometrically connected to balloon 125 and located inprobe 121 (e.g., in cavity 503), in handle 111, or in the control unit.The pressure sensor may visually display an indication of a pressureinside balloon 125 on handle 111, for example, a gauge, a light, adigital display, etc. Providing an indication of pressure enables a userto determine a preferred pressure and to repeatably return to thatpressure. The pressure sensor may be configured to communicate (viawires or wirelessly) pressure information to processing electronics 801.For example, the pressure sensor may generate a response information(e.g., a signal indicative of the rise in pressure caused by contractiveforce of the muscles on balloon 125) triggered by the electricalstimulation provided by electrodes 129 or by the user manually (e.g.,consciously, volitionally, voluntarily, etc.) forcing a contraction ofher pelvic floor muscles. Tracking response information enables a userto determine progress in pelvic floor muscle toning.

According to an exemplary embodiment, neck portion 123 of probe 121includes an external annular groove 523 and an internal annular groove525. Internal annular groove 525 is configured to fit over a radialperiphery of bulkhead 219, and a sealant (e.g., silicone glue) may beused between internal annular groove 525 and bulkhead 219 to form asubstantially airtight seal. Proximate bulkhead 219, left handle portion203 and right handle portion 205 cooperate to form a substantiallycylindrical portion 527 and an inwardly extending annular flange 529.Substantially cylindrical portion 527 fits over neck portion 123 ofprobe 121 and helps to hold internal annular groove 525 against bulkhead219. Inwardly extending flange 529 fits into external annular groove 523of probe 121. Accordingly, neck portion 123 and handle 111 areconfigured to prevent balloon 125 from slipping free of handle 111.

Referring to FIGS. 18A and 18B, shaft 211 is shown to be axially locatedwithin cavity 531 of probe 121. According to the exemplary embodiment,shaft 211 is configured to provide sufficient rigidity to probe 121 tofacilitate insertion of probe 121 into a vagina. Shaft 211 may include aplurality of portions (e.g., members, structures, regions, webs, etc.),shown as ribs 611, configured to support balloon 125. Ribs 611 a maysupport bellows 131 and inhibit bellows 131 from collapsing into cavity531. Balloon 125 may include a plurality of structures (stiffeners,portions, etc.), shown as lugs 613, which are shown to rest on ribs 611b when balloon 125 is in a fully deflated state. Lugs 613 providecushioning between shaft 211 and a user. Lugs 613 may also stiffenportions of balloon 125 underneath electrodes 129, thereby reducingflexure of balloon 125 in the area of the electrode. As shown, bellows131, lugs 613 and ribs 611 are configured to cooperate to maintain asubstantially round shape to probe 121 when balloon 125 is in a deflatedstate.

Operation of device 101 is described below according to an exemplaryembodiment. A method for toning pelvic floor muscles in a femaleincludes inserting probe 121 into the vagina, pressurizing balloon 125to inflate balloon 125 such that electrodes 129 contact the walls of thevagina (e.g., to place electrodes 129 snugly against the walls of thevagina to provide an electrical conduction pathway from the electrodesto the muscles and/or associated nerves), and periodically supplying apulsed electrical stimulation to electrodes 129 to stimulate themuscles. In this manner, balloon 125 allows device 101 to ensure aproper fit with anatomies of different sizes. As the muscles contract inresponse to the electrical stimulation, the walls of the vagina exert aforce on inflated balloon 125, and as the muscles contract, balloon 125is compressed. Device 101 may include a pressure sensor configured togenerate a signal indicative of the contractive force of the muscles onballoon 125 triggered by the electrical stimulation provided through theelectrodes 129. The signal from the pressure sensor may be communicated(e.g., via wired or wireless connections) to processing electronics 801.Processing electronics 801 may be configured to process the signal fromthe pressure sensor to determine information related to musclecontraction caused by the electrical stimulation (e.g., the force orstrength of muscle contraction, the duration of muscle contraction,etc.). When muscle contraction stops, the air pressure within balloon125 causes balloon 125 to expand to original inflated size. The methodalso includes using a biphasic pulse. The progress of the toningexercises can be monitored by evaluating the increase in strength ofmuscle activity by measuring muscle contraction over a number ofexercise sessions. Toning exercises me be particularly useful for womenwho have recently given birth. According to one embodiment, device 101may be used three weeks after childbirth. A method for causing apleasurable sensation in a user may include similar steps as well as thesteps of causing the vibration of clitoral and/or G-Spot stimulators.The pleasurable sensation may be used to cause an orgasm, which in turncauses a release of serotonin and norepinephrine in the user which mayimprove the user's mood and treat depression, specifically post-partumdepression.

According to the exemplary embodiment described, processing electronics801 supply a biphasic pulse of electrical current to electrodes 129which in turn stimulates contraction of the muscles. For example, thebiphasic pulse may have a first stimulation phase providing a pulse at12 hertz for 6 seconds followed by a first rest period having a durationof 6 seconds. A second stimulation phase providing a pulse at 25 hertzfor six seconds follows the first rest period, and a second rest periodhaving a duration of 6 seconds follows the second phase. The use of abiphasic pulse (e.g., a pulse having two stimulation periods havingdifferent frequencies) prevents the muscles from becoming adjusted orde-sensitized to the electrical stimulation. In another embodiment, amultiphasic pulse (e.g., a plurality of different pulse durations and/orfrequency between pulses) may be used. This sequence of stimulationphases and rest phases repeats for a treatment period as necessary. Atypical treatment period is approximately 15 minutes. In otherembodiments, other frequencies and/or durations for the stimulationphases and/or rest periods may be used. For example, in one embodiment,the frequency delivered may be variable, and frequencies up to 50 hertzmay be delivered. Within each stimulation phase, a symmetric alternatingcurrent may be applied to the muscle via electrodes 129 to reduce theeffects of electrophoresis or cataphoresis on the muscle tissues. Forexample, applying a current of a positive first value for a firstpulsewidth (e.g., 200 microseconds), applying no current for 40microseconds, and then applying a current of a negative first value fora first value (e.g., 200 microseconds) limits the migration of ions withthe muscle tissue. This pattern of alternating current pulsewidths maythen be repeated at various frequencies (hertz), e.g., 12 hertz, 25hertz, 50 hertz, etc. Accordingly, the amount of time between the end ofthe negative current until the beginning of the positive current dependson the frequency. Placing a short rest period (e.g., 40 microseconds)between the bipolar phases may improve circuit reliability.

In the embodiment shown, device 101 may be operated at five differentlevels of electrical stimulation. In one embodiment, the lowest level ofelectrical stimulation corresponds to an electrical stimulation currentof 10 milliamps, with each subsequent level increasing the electricalstimulation by 10 milliamps such that the second through fifth levelscorrespond to 20, 30, 40, and 50 milliamps, respectively. In thisembodiment, five lamps 178 are illuminated to correspond with thecurrent operating level of the corresponding stimulation element, andthe electrical stimulation current is delivered in a series ofelectrical stimulation phases separated by rest periods as discussedabove. According to another embodiment, electronics 801 supply abiphasic pulse of electrical potential between electrodes 129. Theelectrical potential between electrodes 129 may have five differentlevels ranging between 10 Volts and 60 Volts. According to anotherembodiment, stimulation may occur as low as 4-5 Volts. Contraction ofthe muscle is a function of current (or voltage) amplitude, pulsewidth,and frequency applied to the muscle. Further, the rate at which themuscle relaxes has a minimum persistence time that is affected by thestrength and duration of the contraction. If the period (i.e.,1/frequency) of stimulation is greater than the minimum persistence timeof the contraction, a user may perceive the stimulation as convulsionsrather than a continuous contraction. Accordingly, processingelectronics 801 may be configured to control one of frequency,pulsewidth, and amplitude in order to maintain a contraction perceivedby the user as substantially continuous. According to one embodiment,processing electronics 801 may be configured to control one offrequency, pulsewidth, and amplitude based on the other two in order tomaintain a substantially continuous contraction. Additionally,processing electronics 801 may be configured to ramp at least one offrequency, amplitude, and pulsewidth at the beginning and/or end of eachphase. Ramping the frequency, amplitude, and/or pulsewidth may reducethe step function of stimulation entering a phase, which may beuncomfortable or startling for some users. According to one embodiment,the pulsewidth may be stepped up by a fraction of the desired pulsewidth(e.g., 50 microseconds) per cycle until the desired pulsewidth (e.g.,200 microseconds) is reached. Processing electronics 801 may inhibitcertain combinations of frequency, current, and voltage. It is believedthat these ranges of currents and voltages provide stimulative andtoning benefits. In various embodiments, the user, via a control 174located on a remote control unit, may control the frequency of theelectrical signal being supplied, may control the current deliveredduring each stimulation phase, or may control the voltage deliveredduring each stimulation phase.

Device 101 may also be operated at multiple, different levels ofvibration stimulation intensity. In one embodiment, the user may controlthe amplitude of vibration generated by the first and second vibratingelements 133, 141 to five different levels, and, in another embodiment,the user may control the frequency of vibration generated by the firstand second vibrating elements 133, 141 to five different levels. In thisembodiment, indication of vibration level is provided haptically to theuser (i.e., the user can feel the level of vibration); however,according to other embodiments, five lamps 178 may be illuminated tocorrespond with the present operating level of the correspondingvibrating element 133, 141. In the embodiment shown, the first andsecond vibrating actuators 533, 537 may be controlled independently ofeach other, and, in this embodiment, interface 115 may include a firstpair of vibration control buttons 174 that control vibrations of thefirst vibrating element 133 and a second pair of vibration controlbuttons 174 that control the vibration of the second vibrating element141. In another embodiment, both the first vibrating actuator 533 andthe second vibrating actuator 537 are controlled together based upon thevibration level selected by the user by interacting with the vibrationcontrol buttons 174.

In the exemplary embodiment described, the level of stimulation and thelevel of vibration are controllable independently and separately fromeach other via interaction with the independent stimulation andvibration control buttons 174 as discussed above. In another embodiment,the level of electrical stimulation and the level of vibration arecontrollable together such that the user can decrease and increase thelevel of electrical stimulation and the level of vibration together viainteraction with a single set of controls.

According to an alternate embodiment, stimulation device 101 may be onecomponent of a stimulation device system that also includes a handhelddisplay device. The handheld display device includes a display screenand a set of display device controls. The handheld display device may beconfigured to display exciting or erotic material (e.g., videos,pictures, etc.) which may be viewed by the user while using thestimulation device. In one embodiment, the handheld display device mayinclude wireless communication hardware and/or wired communicationshardware that allows the material to be downloaded from a source (e.g.,the internet, a proprietary server, another local computer, etc.). Inone embodiment, the handheld display device may include a local memorydevice which stores the material to be displayed once it is downloaded.The handheld display device may also be configured to stream thematerial directly from the source. The user may control the display ofthe material (e.g., play, pause, rewind, fast-forward, etc.) via thedisplay device controls.

In one embodiment, the handheld display device may be configured tocommunicate with the processing electronics 801 of the stimulationdevice via a communication link or connection. In one embodiment, theoperation of the stimulation device 101 may be controlled based upon anaspect or property of the material displayed on the display device. Insuch embodiments, the processing electronics 801 may receive a signalfrom the handheld display device that provides information related tothe aspect of the material being displayed, and the electronic controlunit is configured to adjust the level of electrical and/or vibrationstimulation based upon the provided information. For example, the levelof electrical and/or vibration stimulation delivered by the stimulationdevice may be altered based on the nature of a scene of the video beingdisplayed.

In another embodiment, the operation of the display device may becontrolled based upon operation of the stimulation device 101. In suchembodiments, a signal indicative of an operating parameter of thestimulation device 101 may be communicated to the display device, andthe operation of the display device may be controlled based upon theoperating parameter. For example, in one embodiment, when thestimulation device 101 is powered on, a corresponding signal may betransmitted to the display device causing the display device to poweron. As another example, if the stimulation device is on and the displaydevice is on and playing a video, turning the stimulation device off bypressing the power button on the electronic control unit may trigger asignal to be generated to the display device which causes the video tobe paused.

Referring to FIG. 19, a block diagram of device 101 is shown accordingto an exemplary embodiment. Device 101 is shown to include a pump 511,electrode 129, sensors 803, and vibrating elements 805. Pump 511 isconfigured to cause inflation of balloon 125 and may be manuallyoperated or motorized. First electrode 129 a and/or second electrode 129b are configured to provide an electrical signal (e.g., current,voltage, frequency, etc.) to a muscle in communication with theelectrode. According to various embodiments, device 101 may have one ora plurality of electrodes 129 and may include one or more sensors 803(e.g., a capacitive sensor, a pressure sensor, a conductivity sensor,etc.). Sensors 803 may be disposed in any suitable location in device101 (e.g., in handle 111, in cavity 503 under G-Spot stimulator 133,etc.). Vibrating elements 805 (e.g., G-Spot stimulator 133, clitoralstimulator 141, actuation motors 533, 537, etc.) may each have avibrating motor or may share a vibrating motor, and may be configured toprovide a pleasurable sensation to a user or to provide haptic feedbackto a user, the haptic feedback being in response to user input throughcontrols 174 or as an indication that balloon 125 has been inflated to apredetermined pressure. The pleasurable sensation may induce a user tomaintain compliance with an exercise regimen.

According to an exemplary embodiment, device 101 is shown to includecontrol inputs 174, lamps 178, 172, display 811, audio device 813,processing electronics 801, probe controller circuit 807, and powersupply 809. The control inputs may include any suitable user interface,e.g., buttons 174, toggles, switches, an electro-acoustic transducerconfigured to receive voice commands, a touch sensitive display, etc.Lamps such as lamps 178, 172 may provide information to a user throughillumination, brightness, color, blinking pattern, and/or illuminationof a subset of a plurality of spatially oriented lamps. Display 811 mayalso be configured to provide alphanumeric or graphical images and mayinclude a touchscreen (e.g., touch sensitive surface), the touchscreenbeing configured to both provide information to a user and to receiveinput from a user. Using a touchscreen would provide an easy to cleansurface, thereby facilitating sanitary hygiene. Audio device 813 may bea speaker configured to provide aural information to a user and may becombined with or separate from the electro-acoustic transducer controlinput. Audio device 813 may be configured to provide motivation and/oraudio instruction to a user, to announce that the pressure insideballoon 125 has reached a predetermined level, or to request a user tomanually force a contraction of the muscle in communication withelectrodes 129. Probe controller circuit 807 may include any number ofmechanical or electrical circuitry components or modules for a pump 511,electrode 129, sensors 803, and/or vibrating elements 805 of device 101.For example, circuit 807 may be configured to send electrical signals topelvic floor muscles while sending response information to processingelectronics 801.

Device 101 is further shown to include a power supply 809. Power supply809 is configured to provide electrical power to device 101 andcomponents thereof. According to an exemplary embodiment, device 101 isconfigured to be powered by a 6 Volt source (e.g. four AA batterieslocated in shaft 211 or a 6-Volt battery). According to otherembodiments, device 101 may use other voltages, a rechargeable battery,or may be plugged into utility power supply. Power supply 809 orprocessing electronics 801 may be configured to increase the voltageand/or amperage available to electrodes 129. According to oneembodiment, the maximum electrical potential generated between the firstelectrode 129 a and second electrode 129 b is approximately 80 Volts.According to another embodiment, it is believed that the maximumtherapeutic range of the electrical potential generated between firstelectrode 129 a and second electrode 129 b is approximately 50 Volts.According to the exemplary embodiment, power supply 809 and/orprocessing electronics 801 are configured to provide power to 3-Voltmotors used in vibrating elements 805.

Referring to FIG. 20, a detailed block diagram of processing electronics801 of FIG. 19 is shown, according to an exemplary embodiment.Processing electronics 801 includes a processor 911 and a memory 921.According to an exemplary embodiment, processor 911 is configured toexecute computer code stored in memory 921 to complete and facilitatethe activities described herein. For example, memory 921 is shown toinclude modules 923-941 which are computer code modules (e.g.,executable code, object code, source code, script code, machine code,etc.) configured for execution by processor 911. When executed byprocessor 911, processing electronics 801 is configured to complete theactivities described herein. Processing electronics includes hardwarecircuitry for supporting the execution of the computer code of modules923-941. For example, processing electronics 801 includes hardwareinterfaces (e.g., output 951) for communicating control signals (e.g.,analog, digital) from processing electronics 801 to circuit 807.Processing electronics 801 may also include an input 956 for receiving,for example, sensor data from circuit 807, response information fromcircuit 807, user inputs from control inputs 174, or for receiving dataor signals from other systems or devices. According to variousembodiments, processor 911 may be or include one or moremicroprocessors, an application specific integrated circuit (ASIC), acircuit containing one or more processing components, a group ofdistributed processing components, circuitry for supporting amicroprocessor, or other hardware configured for processing. Memory 921can be any volatile or non-volatile memory device capable of storingdata or computer code relating to the activities described herein.

Memory 921 includes a memory buffer 923 for receiving sensor data, forexample response information, pressure data, voltage data, capacitivesensing data, conductivity data, etc. The sensor data may be stored inmemory buffer 923 until buffer 923 is accessed for data. For example, aprogram module 929, electrode module 931, vibration 933, conductivitymodule 935, inflation module 937, position module 939, pressure module941, or another process that uses sensor data may access buffer 923. Thesensor data stored in memory 921 may be stored according to a variety ofschemes or formats. For example, the sensor data may be stored asstreaming data, peak values, synchronous, asynchronous, separate buffersfor each data type, one buffer for all sensor data, or any othersuitable format for storing sensor information.

Memory 921 further includes configuration data 925. Configuration data925 includes data relating to device 101, such as electrode informationthat the electrode module 931 can interpret to determine how to commandthe electrodes 129 to cause a muscle contraction, for example the numberof electrodes, electrode conductivity, conductivity as a function ofexpansion or pressure, etc. According to another embodiment,configuration data 925 may include pump information, such as whether thepump 511 is hand-operated or motorized, and control information of themotorized pump. According to another embodiment, configuration data 925may include sensor information, such as the existence, location, andcalibration of pressure sensors, conductivity sensors, capacitivesensors, and the like. According to another embodiment, configurationdata 925 may include response information configuration data whichprogram module 929 can interpret to determine if the responseinformation will include an electrical signal received from at least oneof the electrodes 129, a pressure signal received from a pressuresensor, or both.

Memory 921 further includes a program data 927 which includes datarelating to the toning program or stimulation program. Program data 927may include data that program module 929 can interpret to determine howto command the electrical signal sent to electrodes 129. For example,program data 927 may include electrical stimulation data including datarelating to current, voltage, frequency, number of phases of stimulationsignal, duration and pattern of stimulation periods, and/or duration andpattern of rest periods. Program data 927 may include vibrationalstimulation data including data relating to vibration, frequency,pattern, etc. Program data 927 may be stored in memory 921 by the useror another, may be downloaded into memory 921, and may be synchronizedwith audio or video files.

Memory 921 further includes a program module 929 which includes logicfor using configuration data 925, program data 927, sensor data from thememory buffer 923, and/or data received from another module to carry outthe pleasurable sensations or muscle toning program, e.g., providingstimulation commands to electrode module 931 or vibration module 933.Program module 929 may output data to a data logging module forrecording, may cause outputs for providing an indication to a user, andmay cause an output requesting a user to perform an activity (e.g.,inserting probe 121, pressurizing balloon 125, forcing a contraction,etc.). Program module 929 may include logic to cause closed-loop controlof the electrical stimulation and/or vibrational stimulation based onresponse information received from memory buffer 923, electrode module931, conductivity module 935, and/or pressure module 941.

Memory 921 further includes an electrode module 931 which includes logicfor causing a contraction of a muscle in communication with electrode129. Electrode module 931 may control the stimulation of a muscle incommunication with electrodes 129 based on conductivity informationreceived from conductivity module 935, position information receivedfrom position module 939, and/or pressure information received frompressure module 941. Electrode module 931 may include logic to controlthe current or voltage provided by electrodes 129 as a function offrequency, or to control the frequency in response to the current orvoltage. According to the exemplary embodiment, electrode module 931 maybe configured to operate at five levels of stimulation, which may beindicated to a user using the five lamps 178 shown on interface 115.According to an alternate embodiment, electrode module 931 may includelogic to use an 8-bit register to control the frequency, current, orvoltage of the stimulation. Using an 8-bit register provides fineresolution for precise stimulation effects and toning.

Memory 921 further includes a vibration module 933 which includes logicfor causing a vibrating element to vibrate. Vibration module 933 mayinclude logic for actuating G-Spot vibration actuator 533, clitoralvibration actuator 537, and a haptic feedback motor. For example,actuators 533 and 537 may be actuated dependently or independently andmay be actuated in response to user input through controls 174, inresponse to response information, or synchronized with music or video.Vibration module 933 may operate actuators 533 and 537 at five differentlevels of vibration. Vibration module 933 may receive data from memorybuffer 923, program data 927, and program module 929.

Memory 921 is shown to include a conductivity module 935 which includeslogic for determining the conductivity of the environment of probe 121,balloon 125, and/or electrodes 129. Conductivity of the environment isdependent on many factors. For example, conductivity may depend on theconductivity and quantity of artificial lubricants used, the quantity ofvaginal fluid present, which may change from day to day or during use,and/or the expansion of electrodes 129. A conductivity sensor in probe121 may measure the resistivity between electrodes 129 or measure thecurrent delivered for a provided voltage. According to one embodiment, alow voltage (e.g., 2 Volts) may be provided across electrodes 129, theresulting current is measured, and resistance is calculated. The lowvoltage may be provided before beginning a toning or exercise program ormay be provided during a portion of a rest period (e.g., betweenphases). Conductivity module 935 may receive sensor data directly orthrough memory buffer 923. Conductivity module 935 may provideconductivity information to electrode module 931 or any other modulerequiring conductivity information.

Memory 921 is shown to include an inflation module 937 which includeslogic for providing an indication to a user that the pressure insideballoon 125 has reached a predetermined value. According to oneembodiment, the predetermined value is a pressure stored in program data927. Inflation module 937 may use sensor data from memory buffer 923 orpressure information from pressure module 941. Inflation module 937 mayinclude logic for causing inflation of balloon 125. For example,inflation module 937 may cause a request for a user to actuate pump 511or may cause actuation of a motorized pump 511. Inflation module 937 maycontrol pump 511 using configuration data 925 and pressure data receivedfrom memory buffer 923 or pressure module 941.

Memory 921 is shown to include a position module 939 which includeslogic for determining if probe 121 is inserted and/or properlypositioned. According to one embodiment, position module 939 may receivecapacitive sensor data from memory buffer 923. According to analternative embodiment, position module 939 may determine insertion ofprobe 121 from a change in continuity or a change in resistance betweenelectrodes 129. According to another alternative embodiment, positionmodule 939 may request user confirmation that probe 121 and/or balloon125 are inserted, for example, by providing input via control inputs 174on controller 104. Position module 939 may cause output from electrodemodule 931 to be inhibited if position module 939 determines thatballoon 125 has been removed from the vagina. For example, positionmodule 939 may cause electrodes 129 to stop providing an electricsignal, or position module 939 may provide position information toprogram module 929 or to electrode module 931.

Memory 921 further includes a pressure module 941 which includes logicfor determining the pressure inside balloon 125. Pressure module 941 mayuse configuration data 925, pressure data received directly from thepressure sensor, or pressure data received from memory buffer 923.Pressure module 941 may provide pressure information to inflation module937 and program module 929. Pressure module 941 may provide pressureinformation to electrode module 931, or may inhibit processingelectronics 801 from causing a contraction of the muscle if the pressurein balloon 125 is below a threshold value, e.g., balloon 125 has notbeen sufficiently inflated. Pressure module 941 may receive responseinformation from the pressure sensor.

Referring to FIG. 21, a flowchart of a process 1001 for toning pelvicfloor muscles is shown according to an exemplary embodiment. Process1001 is shown to include the steps of providing a device as describedabove and including an expandable portion having an outer surface, afirst electrode, and a second electrode (step 1003). Process 1001further includes the steps of causing the expandable portion to inflatesuch that the first and second electrodes contact vaginal walls (step1003), and causing a contraction of the muscle in communication with theelectrodes (step 1007). Process 1001 further includes causing avibrating element to impart vibration to a first portion of a user'sbody (step 1009). According to one embodiment, the first and secondelectrodes couple to the outer surface of the expandable portion and areconfigured to cause a contraction of a muscle and communication with theelectrodes. According to alternate embodiments, process 1001 may includeadditional or fewer steps. For example, process 1001 may includeinserting the expandable portion in a vaginal cavity, deflating theexpandable portion, and removing the probe from the vaginal cavity andmay not include causing a vibrating element to impart vibration (step1009).

Referring to FIG. 22, a flowchart of process 1101 for toning pelvicfloor muscles is shown according to an exemplary embodiment. Process1101 is shown to include the steps of providing a device as describedabove and including a balloon having an outer surface, a firstelectrode, and a second electrode (step 1103) and inserting the ballooninto a vaginal cavity (step 1105). Process 1101 further includes thesteps of causing inflation of the balloon such that at least one of thefirst and second electrodes press against at least one vaginal wall(step 1107) and causing the balloon to inflate in a radially non-uniformmanner (step 1109). According to various embodiments, step 1107 mayinclude requesting a user to actuate pump 511, causing actuation of pump511, and/or causing operation of a motorized pump. Step 1109 may includeunfolding of bellows or non-uniform expansion of balloon portions havingdifferent thicknesses. Process 1101 is shown to include the steps ofproviding a pattern of at least one of current, voltage, and frequency(step 1111), causing a contraction of a muscle in communication with theelectrodes (step 1113), causing a first vibrating element to impartvibration to a first portion of a user's body (step 1115), and causing asecond vibrating element to impart vibration to a second portion of auser's body (step 1117). Providing the pattern in step 1111 may or maynot cause the contraction or vibrations in steps 1113-1117, and thecontraction and vibrations in steps 1113-1117 may be caused by the sameor different electrical signals. Causing a contraction of a muscle instep 1113 may be through electrical stimulation via electrodes 129 ormay be requesting a user to manually or volitionally force a contractionof the muscle. The balloon may then be deflated (step 1119) and removedfrom the vaginal cavity (step 1121).

Various alternate embodiments of the process described are contemplated.For example, the order of steps may be changed, e.g., causing acontraction of a muscle (step 1113), causing a first vibrating elementto impart vibration (step 1115), and causing a second vibrating elementto impart vibration (1117) may occur in any order, may occursimultaneously, or may occur repeatedly. Process 1101 may not includeall of the steps listed, e.g., not include causing first or secondvibrating elements to impart vibration (steps 1115 and 1117). Process1101 may include additional steps, e.g., lubricating the balloon orrequesting insertion of the balloon into a vaginal cavity, for example,by indicating that device 101 is initialized and ready for insertion(e.g., illuminating in indicator lamp 172), providing an aural requestthrough speaker audio device 813, or providing instructions along withproviding device 101.

It is also important to note that the construction and arrangement ofthe elements of the devices as shown in the exemplary embodiments areillustrative only. Although only a few embodiments of the presentdisclosure have been described in detail, those skilled in the art whoreview this disclosure will readily appreciate that many modificationsare possible (e.g., variations in sizes, dimensions, structures, shapesand proportions of the various elements, values of parameters, mountingarrangements, use of materials, colors, orientations, etc.) withoutmaterially departing from the novel teachings and advantages of thesubject matter recited. For example, elements shown as integrally formedmay be constructed of multiple parts or elements. It should be notedthat the elements and/or assemblies of the enclosure may be constructedfrom any of a wide variety of materials that provide sufficient strengthor durability, in any of a wide variety of colors, textures, andcombinations. Additionally, in the subject description, the word“exemplary” is used to mean serving as an example, instance orillustration. Any embodiment or design described herein as “exemplary”is not necessarily to be construed as preferred or advantageous overother embodiments or designs. Rather, use of the word exemplary isintended to present concepts in a concrete manner. Accordingly, all suchmodifications are intended to be included within the scope of thepresent inventions. Other substitutions, modifications, changes, andomissions may be made in the design, operating conditions, andarrangement of the preferred and other exemplary embodiments withoutdeparting from the spirit of the appended claims. Anymeans-plus-function clause is intended to cover the structures describedherein as performing the recited function and not only structuralequivalents but also equivalent structures.

The present disclosure contemplates methods, systems and programproducts on any machine-readable media for accomplishing variousoperations. The embodiments of the present disclosure may be implementedusing existing computer processors, or by a special purpose computerprocessor for an appropriate system, incorporated for this or anotherpurpose, or by a hardwired system. Embodiments within the scope of thepresent disclosure include program products comprising machine-readablemedia for carrying or having machine-executable instructions or datastructures stored thereon. Such machine-readable media can be anyavailable media that can be accessed by a general purpose or specialpurpose computer or other machine with a processor. By way of example,such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROMor other optical disk storage, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to carry or storedesired program code in the form of machine-executable instructions ordata structures and which can be accessed by a general purpose orspecial purpose computer or other machine with a processor. Wheninformation is transferred or provided over a network or anothercommunications connection (either hardwired, wireless, or a combinationof hardwired or wireless) to a machine, the machine properly views theconnection as a machine-readable medium. Thus, any such connection isproperly termed a machine-readable medium. Combinations of the above arealso included within the scope of machine-readable media.Machine-executable instructions include, for example, instructions anddata which cause a general purpose computer, special purpose computer,or special purpose processing machines to perform a certain function orgroup of functions.

Although the figures may show a specific order of method steps, theorder of the steps may differ from what is depicted. Also two or moresteps may be performed concurrently or with partial concurrence. Suchvariation will depend on the software and hardware systems chosen and ondesigner choice. All such variations are within the scope of thedisclosure. Likewise, software implementations could be accomplishedwith standard programming techniques with rule based logic and otherlogic to accomplish the various connection steps, processing steps,comparison steps and decision steps. Other substitutions, modifications,changes and omissions may be made in the design, operatingconfiguration, and arrangement of the preferred and other exemplaryembodiments without departing from the spirit of the appended claims.

What is claimed is:
 1. An apparatus for the treatment of urinaryincontinence comprising: a shaft; a balloon surrounding at least aportion of the shaft and configured for movement between an inflatedstate and a deflated state; a first electrode coupled to a first portionof an outer surface of the balloon, the first electrode configured tocause a contraction of at least one muscle in communication with thefirst electrode; a second portion of outer surface of the balloon havinga longitudinal fold having a thickness less than the first portion ofthe balloon and separating the first portion from a third portion of theouter surface of the balloon along a longitudinal axis of the shaft, thesecond portion being exposed to an exterior of the apparatus when theballoon is in the deflated state; and a second electrode coupled to thethird portion; wherein the balloon is configured to inflate in aradially non-uniform manner in response to the difference in thicknessesof the first portion and the second portion.
 2. The apparatus of claim 1comprising a pump in communication with the balloon and configured tocause inflation of the balloon such that at least one of the first andsecond electrodes press against a vaginal wall of a user.
 3. Theapparatus of claim 1 comprising processing electronics configured toinhibit at least one of the first and second electrodes from causing acontraction of the at least one muscle in communication with the atleast one of the first and second electrodes until the balloon has beeninflated to a predetermined pressure.
 4. The apparatus of claim 1comprising processing electronics configured to cause an indication inresponse to a determination that a pressure inside the balloon hasreached a predetermined value.
 5. The apparatus of claim 1 comprisingprocessing electronics configured to cause an indication in response toa determination that the balloon has been inflated to a pressure equalto or greater than a predetermined value.
 6. The apparatus of claim 1comprising processing electronics configured to cause inflation of theballoon.
 7. The apparatus of claim 1 comprising processing electronicsconfigured to cause a current of between 10 milliamps and 50 milliamps.8. The apparatus of claim 1 comprising processing electronics configuredto cause an electric potential difference between the first electrodeand the second electrode.
 9. The apparatus of claim 8, wherein theelectric potential difference is between 0 and 80 Volts.
 10. Theapparatus of claim 8, wherein the electric potential difference isbetween 10 Volts and 50 Volts.
 11. The apparatus of claim 8, wherein theprocessing electronics are configured to control the electric potentialdifference.
 12. A stimulation device for creating a pleasurablesensation in a user comprising: an expandable portion configured toassume a plurality of states of expansion between minimum expansion andmaximum expansion; a vibrating element spaced from an outer surface ofthe expandable portion; and an electrode coupled to the outer surface ofthe expandable portion, the electrode configured to transmit electricalcurrent to a muscle in communication with the electrode to cause acontraction of the muscle; the expandable portion comprising a firstportion and a second portion, the first and second portions separated bya longitudinal fold, the electrode coupled to the first portion and thevibrating element adjacent to one of the first and second portions,wherein the longitudinal fold is exposed to an exterior of thestimulation device when in a non-expanded state.
 13. The device of claim12 comprising processing electronics configured to cause an electricalsignal in the electrode and to control an aspect of vibration of thevibrating element, wherein the electrode is coupled to a top surface ofthe outer surface of the expandable portion.
 14. The device of claim 12,wherein the vibrating element is configured to impart vibration to afirst portion of the user's body.
 15. The device of claim 12 comprisinga second vibrating element configured to impart vibration to a secondportion of the user's body.
 16. The device of claim 12, wherein theexpandable portion is configured to be inserted into a vagina.
 17. Thedevice of claim 12 comprising a pump in communication with theexpandable portion and configured to cause inflation of the expandableportion.
 18. The device of claim 13, wherein the electrode is formed ofan expandable material.
 19. The device of claim 18, wherein theexpandable material is an electrically conductive silicone rubber.
 20. Astimulation device for creating a pleasurable sensation in a usercomprising: a shaft having a proximal end and a distal end, the proximalend being interconnected to a housing; an operative portion locatedbetween the proximal end and the distal end and configured to be locatedwithin at least one of a vagina, an anal canal, and a rectum when thedevice is in an inserted position; only one balloon circumferentiallysurrounding the operative portion of the shaft, the balloon comprisingfirst and second surfaces separated by a longitudinal fold; and a firstelectrode and a second electrode, the first and second electrodesdisposed on the first and second surfaces, respectively, of the balloonand configured to cause a contraction of a muscle in communication withthe first and second electrodes; wherein the balloon is configured toinflate such that the first and second electrodes press against at leastone wall of the at least one of a vagina, an anal canal, and a rectum.